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## Complete Summary

#### GUIDELINE TITLE

Treatment: fluid resuscitation. In: Guidelines for the prehospital
management of severe traumatic brain injury, second edition.

#### BIBLIOGRAPHIC SOURCE(S)

Treatment: fluid resuscitation. In: Badjatia N, Carney N, Crocco TJ,
Fallat ME, Hennes HM, Jagoda AS, Jernigan S, Lerner EB, Letarte PB,
Moriarty T, Pons PT, Sasser S, Scalea TM, Schleien C, Wright DW.
Guidelines for prehospital management of traumatic brain injury. 2nd ed.
New York (NY): Brain Trauma Foundation; 2007. p. 61-70. \[21
references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Brain Trauma Foundation.
Guidelines for prehospital management of traumatic brain injury. New
York (NY): Brain Trauma Foundation; 2000. 81 p.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

-   Traumatic brain injury (TBI)

-   Hypotension

#### GUIDELINE CATEGORY

Evaluation\
Management\
Treatment

#### CLINICAL SPECIALTY

Critical Care\
Emergency Medicine\
Neurological Surgery\
Neurology\
Pediatrics

#### INTENDED USERS

Emergency Medical Technicians/Paramedics\
Physicians

#### GUIDELINE OBJECTIVE(S)

-   To provide guidelines for the early and appropriate prehospital
    management of traumatic brain injury (TBI)

-   To provide guidance on properly identifying and treating patients
    with TBI who need fluid resuscitation

#### TARGET POPULATION

Adults and children with traumatic brain injury

#### INTERVENTIONS AND PRACTICES CONSIDERED

Hypertonic versus isotonic fluid resuscitation

#### MAJOR OUTCOMES CONSIDERED

-   Morbidity and mortality from traumatic brain injury (TBI)

-   Positive predictive value of hypotension for worsened outcome

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

**General Search Strategy**

Four participants were assigned to work on each topic -- two for the
adult section and two for the pediatric section. Participants finalized
the scope of each topic and provided terms for the electronic literature
search.

**Inclusion Criteria**

-   Human subjects

-   Traumatic brain injury (TBI)

-   English language

-   [\>]{.underline}25 subjects

-   Randomized controlled trials (RCTs), cohort studies, case-control
    studies, case series, databases, registries

**Exclusion Criteria**

-   Sample contained \>15% of pediatric patients, or \>15% of patients
    with pathologies other than TBI [AND]{.underline} the data were not
    reported separately (see Appendix C)

-   Wrong independent variable (e.g., the intervention was not specific
    to the topic)

-   Wrong dependent variable (e.g., outcomes were not mortality or
    morbidity, or did not associate with clinical outcomes)

-   Statistics used in the analysis were not appropriate to the research
    design, variables, and/or sample size case studies, editorials,
    comments, letters

Center staff worked with a doctoral-level research librarian to
construct electronic search strategies for each topic from 1996 through
April of 2005 to August 2005 (see Appendix B in the original guideline
document). They used strategies with the highest likelihood of capturing
most of the targeted literature, which resulted in the acquisition of a
large proportion of non-relevant citations. A set of abstracts was sent
to the participants for each topic. Blinded to each others\' work, they
read the abstracts and eliminated citations using the criteria specified
above.

Center staff compared the participants\' selections, identified
discrepancies, and worked with authors to resolve them. A set of
full-text publications was sent to each participant. They read the
publications and determined the final library of studies that would be
used as evidence. Results of the electronic searches were supplemented
by recommendations of peers and by reading reference lists of included
studies.

A second search was conducted from 2005 through July of 2006 to capture
any relevant Class I or II literature that might have been published
since the first literature search in 2005. Relevant publications were
added to those from the original search, constituting the final library
of studies that were used as evidence in this document. The yield of
literature from each phase of the search is presented in Appendix D in
the original guideline document.

**Specific Strategy for This Topic**

For this update Medline was searched from 1996 through July 2006 using
the search strategy for this question (see Appendix B in the original
guideline document), and results were supplemented with literature
recommended by peers or identified from reference lists. For adult
studies, of 15 potentially relevant publications, 1 was added to the
existing table and used as evidence for this question. For pediatric
studies, of 23 potentially relevant publications, no new studies were
included (see Evidence Tables in the original guideline document).

#### NUMBER OF SOURCE DOCUMENTS

8 adult studies and 8 pediatric studies

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

  ------------------------------------------------------------------------
  **Class of         **Study Design**      **Quality Criteria**
  Evidence**                               
  ------------------ --------------------- -------------------------------
  **I**              Good quality          Adequate random assignment
                     randomized controlled method.\
                     trial (RCT)           \
                                           Allocation concealment.\
                                           \
                                           Groups similar at baseline.\
                                           \
                                           Outcome assessors blinded.\
                                           \
                                           Adequate sample size.\
                                           \
                                           Intention-to-treat analysis.\
                                           \
                                           Follow-up rate
                                           [\>]{.underline}85%.\
                                           \
                                           Differential loss to
                                           follow-up.\
                                           \
                                           Maintenance of comparable
                                           groups.

  **II**             Moderate quality RCT  Violation of one or more of the
                                           criteria for a good quality
                                           RCT.^1^

  **II**             Good quality cohort   Blind or independent assessment
                                           in a prospective study, or use
                                           of reliable^2^ data in a
                                           retrospective study.\
                                           \
                                           Comparison of two or more
                                           groups must be clearly
                                           distinguished.\
                                           \
                                           Non-biased selection.\
                                           \
                                           Follow-up rate
                                           [\>]{.underline}85%.\
                                           \
                                           Adequate sample size.\
                                           \
                                           Statistical analysis of
                                           potential confounders.^3^

  **II**             Good quality          Accurate ascertainment of
                     case-control          cases.\
                                           \
                                           Nonbiased selection of
                                           cases/controls with exclusion
                                           criteria applied equally to
                                           both.\
                                           \
                                           Adequate response rate.\
                                           \
                                           Appropriate attention to
                                           potential confounding
                                           variables.

  **III**            Poor quality RCT      Major violations of the
                                           criteria for a good or moderate
                                           quality RCT.^1^

  **III**            Moderate or poor      Violation of one or more
                     quality cohort        criteria for a good quality
                                           cohort.^1^

  **III**            Moderate or poor      Violation of one or more
                     quality case-control  criteria for a good quality
                                           case-control.^1^

  **III**            Case Series,          Prospectively collected data
                     Databases or          that is purely observational,
                     Registries            and retrospectively collected
                                           data.

  ^1^Assessor needs                        
  to make a judgment                       
  about whether one                        
  or more violations                       
  are sufficient to                        
  downgrade Class of                       
  study, based upon                        
  the topic, the                           
  seriousness of the                       
  violation(s),                            
  their potential                          
  impact on the                            
  results, and other                       
  aspects of the                           
  study. Two or                            
  three violations                         
  do not necessarily                       
  constitute a major                       
  flaw. The assessor                       
  needs to make a                          
  coherent argument                        
  why the                                  
  violation(s)                             
  either do, or do                         
  not, warrant a                           
  downgrade.\                              
  \                                        
  ^2^Reliable data                         
  are concrete data                        
  such as mortality                        
  or re-operation.\                        
  \                                        
  ^3^Publication                           
  authors must                             
  provide a                                
  description of                           
  robust baseline                          
  characteristics,                         
  and control for                          
  those that are                           
  unequally                                
  distributed                              
  between treatment                        
  groups.                                  
  ------------------------------------------------------------------------

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Remaining blinded to each other\'s work, participants read each
publication and abstracted data using a predetermined format.

**Quality of Body of Evidence**

Ultimately the individual studies were considered in aggregate, whether
through meta-analyses or through qualitative assessment. Thus, the
strength of recommendations were derived from the quality of the overall
body of evidence used to address the topic.

The quality of the overall body of evidence for each recommendation was
classified as ***high***, ***moderate***, or ***low***. Factors that may
decrease the quality include potential bias, differing findings across
studies, the use of indirect evidence, or lack or precision. For
example, if two or more Class I studies demonstrate contradictory
findings for a particular topic, the overall quality most probably will
be low because there is uncertainty about the effect. Similarly, Class I
or II studies that provide indirect evidence may only constitute low
quality evidence, overall.

**Indirect Evidence**

Well controlled studies conducted in the field are rare. One alternative
is to apply evidence from studies conducted in other environments to
field practice, or from other pathologies to traumatic brain injury
(TBI). In this document, indirect evidence from inhospital populations
or from physiological studies was used, after careful consideration of
the quality of the study for its own population, and then of its
usefulness as indirect evidence. The following sequential process of
questions was used:

1.  To what extent does the physiology of the field application
    approximate the physiology of the inhospital application?

2.  What are the differences in patients, settings, treatments, and
    measurements between the field and inhospital settings?

3.  To what extent would those differences influence the physiology of
    the intervention?

4.  To what extent and in what direction would those differences
    influence the observed effect?

5.  What is the quality of the publication?

6.  Consider all of the above (1) to determine if the publication can be
    used as indirect evidence, and if so, (2) to determine the quality
    of the evidence.

In the original guideline document, indirect evidence used to support a
recommendation is identified as such.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The Brain Trauma Foundation (BTF) and the BTF Center for Guidelines
Management (Center) convened a virtual meeting of previous participants
in the development of *Guidelines for Prehospital Management of
Traumatic Brain Injury*, as well as with colleagues new to the project.
They specified topics for inclusion in the current update, and agreed to
include pediatric literature as a separate section for each topic.
Further refinement of topics and scope was accomplished in a subsequent
work meeting of participants with BTF and Center staff. The group agreed
to maintain the distinction between *Assessment* topics and *Treatment*
topics.

The participants drafted chapters and the entire team gathered for a
2-day work session to discuss the literature base, and to achieve
consensus on classification of quality of evidence, and strength of
recommendations.

After the work meeting, participants revised each topic based on the
group\'s recommendations. Virtual meetings were convened, during which a
subset of approximately five members of the team edited each topic
online.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Strong** recommendations are derived from high quality evidence that
provide precise estimates of the benefits or downsides of the topic
being assessed.

With **weak** recommendations, (1) there is lack of confidence that the
benefits outweigh the downsides, (2) the benefits and downsides may be
equal, and/or (3) there is uncertainty about the degree of benefits and
downsides.

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Final versions were circulated to the Review Committee. Critiques from
the Review Committee were addressed by participants and incorporated, or
not, based upon their accuracy and consistency with the pre-specified
systematic process.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Strength of recommendations (**strong** or **weak**) and quality of
evidence (**Class I-III**) are defined at the end of the \"Major
Recommendations\" field.

***Strength of Recommendations: Weak***.

***Quality of Evidence: Low, from Class III studies, or Class II studies
with contradictory findings***.

**Adult**

A.  Hypotensive patients should be treated with isotonic fluids.

B.  Hypertonic resuscitation is a treatment option for traumatic brain
    injury (TBI) patients with a Glasgow Coma Scale Score (GCS)
    [\<]{.underline}8.

**Pediatric**

A.  For the pediatric TBI patient, hypotension should be treated with
    isotonic solutions.

**Definitions**:

**Quality of Evidence**

  ------------------------------------------------------------------------
  **Class of         **Study Design**      **Quality Criteria**
  Evidence**                               
  ------------------ --------------------- -------------------------------
  **I**              Good quality          Adequate random assignment
                     randomized controlled method.\
                     trial (RCT)           \
                                           Allocation concealment.\
                                           \
                                           Groups similar at baseline.\
                                           \
                                           Outcome assessors blinded.\
                                           \
                                           Adequate sample size.\
                                           \
                                           Intention-to-treat analysis.\
                                           \
                                           Follow-up rate
                                           [\>]{.underline}85%.\
                                           \
                                           Differential loss to
                                           follow-up.\
                                           \
                                           Maintenance of comparable
                                           groups.

  **II**             Moderate quality RCT  Violation of one or more of the
                                           criteria for a good quality
                                           RCT.^1^

  **II**             Good quality cohort   Blind or independent assessment
                                           in a prospective study, or use
                                           of reliable^2^ data in a
                                           retrospective study.\
                                           \
                                           Comparison of two or more
                                           groups must be clearly
                                           distinguished.\
                                           \
                                           Non-biased selection.\
                                           \
                                           Follow-up rate
                                           [\>]{.underline}85%.\
                                           \
                                           Adequate sample size.\
                                           \
                                           Statistical analysis of
                                           potential confounders.^3^

  **II**             Good quality          Accurate ascertainment of
                     case-control          cases.\
                                           \
                                           Nonbiased selection of
                                           cases/controls with exclusion
                                           criteria applied equally to
                                           both.\
                                           \
                                           Adequate response rate.\
                                           \
                                           Appropriate attention to
                                           potential confounding
                                           variables.

  **III**            Poor quality RCT      Major violations of the
                                           criteria for a good or moderate
                                           quality RCT.^1^

  **III**            Moderate or poor      Violation of one or more
                     quality cohort        criteria for a good quality
                                           cohort.^1^

  **III**            Moderate or poor      Violation of one or more
                     quality case-control  criteria for a good quality
                                           case-control.^1^

  **III**            Case Series,          Prospectively collected data
                     Databases or          that is purely observational,
                     Registries            and retrospectively collected
                                           data.

  ^1^Assessor needs                        
  to make a judgment                       
  about whether one                        
  or more violations                       
  are sufficient to                        
  downgrade Class of                       
  study, based upon                        
  the topic, the                           
  seriousness of the                       
  violation(s),                            
  their potential                          
  impact on the                            
  results, and other                       
  aspects of the                           
  study. Two or                            
  three violations                         
  do not necessarily                       
  constitute a major                       
  flaw. The assessor                       
  needs to make a                          
  coherent argument                        
  why the                                  
  violation(s)                             
  either do, or do                         
  not, warrant a                           
  downgrade.\                              
  \                                        
  ^2^Reliable data                         
  are concrete data                        
  such as mortality                        
  or re-operation.\                        
  \                                        
  ^3^Publication                           
  authors must                             
  provide a                                
  description of                           
  robust baseline                          
  characteristics,                         
  and control for                          
  those that are                           
  unequally                                
  distributed                              
  between treatment                        
  groups.                                  
  ------------------------------------------------------------------------

**Strength of Recommendation**

**Strong** recommendations are derived from high quality evidence that
provide precise estimates of the benefits or downsides of the topic
being assessed.

With **weak** recommendations, (1) there is lack of confidence that the
benefits outweigh the downsides, (2) the benefits and downsides may be
equal, and/or (3) there is uncertainty about the degree of benefits and
downsides.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each
recommendation (see the \"Major Recommendations\" field).

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Reduction in morbidity or mortality from severe traumatic brain injury
(TBI) with prehospital hypotension management

#### POTENTIAL HARMS

Not stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

The information contained in these Guidelines, which reflects the
current state of knowledge at the time of completion of the literature
search (July 2006), is intended to provide accurate and authoritative
information about the subject matter covered. Because there will be
future developments in scientific information and technology, it is
anticipated that there will be periodic review and updating of these
Guidelines. These Guidelines are distributed with the understanding that
the Brain Trauma Foundation, the National Highway Traffic Safety
Administration, and the other organizations that have collaborated in
the development of these Guidelines are not engaged in rendering
professional medical services. If medical advice or assistance is
required, the services of a competent physician should be sought. The
recommendations contained in these Guidelines may not be appropriate for
use in all circumstances. The decision to adopt a particular
recommendation contained in these Guidelines must be based on the
judgment of medical personnel, who take into consideration the facts and
circumstances in each case, and on the available resources.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Treatment: fluid resuscitation. In: Badjatia N, Carney N, Crocco TJ,
Fallat ME, Hennes HM, Jagoda AS, Jernigan S, Lerner EB, Letarte PB,
Moriarty T, Pons PT, Sasser S, Scalea TM, Schleien C, Wright DW.
Guidelines for prehospital management of traumatic brain injury. 2nd ed.
New York (NY): Brain Trauma Foundation; 2007. p. 61-70. \[21
references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2000 (revised 2007)

#### GUIDELINE DEVELOPER(S)

Brain Trauma Foundation - Disease Specific Society\
National Highway Traffic Safety Administration - Federal Government
Agency \[U.S.\]

#### SOURCE(S) OF FUNDING

Brain Trauma Foundation

National Highway Traffic Safety Administration

#### GUIDELINE COMMITTEE

Not stated

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Authors*: Neeraj Badjatia, MD; Nancy Carney, PhD; Todd J. Crocco, MD;
Mary Elizabeth Fallat, MD, FACS; Halim M. A. Hennes, MD, FAAP; Andy S.
Jagoda, MD, FACEP; Sarah Jernigan, MD; E. Brooke Lerner, PhD; Peter B.
Letarte, MD, FACS; Thomas Moriarty, MD; Peter T. Pons, MD, FACEP; Scott
Sasser, MD; Thomas M. Scalea, MD, FACS; Charles Schleien, MD; David W.
Wright, MD

*Participants*: John E. Campbell, MD, FACEP; Pamela Drexel, Brain Trauma
Foundation; Jamshid Ghajar, MD, PhD; Lauren Post, MD; Andrew W. Stern,
NREMT-P, MPA, MA

*Review Committee*: P. David Adelson, MD, FACS, FAAP; Arthur Cooper, MD,
FACS; Thomas J. Esposito, MD, MPH, FACS; John William Jermyn, DO, FACEP;
Tom Judge, CCT-P; Carsten Kock-Jensen, MD, Chair, Scandinavian
Neurotrauma Committee; Jon R. Krohmer, MD, FACEP; Anthony Marmarou, PhD;
Lawrence Marshall, MD; Stephan Mayer, MD; Connie A. Meyer, MICT; Robert
E. O\'Connor, MD, MPH, FACEP; Jeffrey P. Salomone, MD, FACS; Snorre
Sollid, MD, Scandinavian Neurotrauma Committee; Andreas Unterberg, MD;
Alex B. Valadka, MD, FACS; Walter Videtta, MD; Robert K. Waddell II,
NAEMT; Beverly Walters, MD, FACS

*Education Subcommittee*: Cathy Case, EMT-P; Debra Cason, RN; John
Gosford; Joseph A. Grafft; Jon R. Krohmer, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Brain Trauma Foundation.
Guidelines for prehospital management of traumatic brain injury. New
York (NY): Brain Trauma Foundation; 2000. 81 p.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[Brain Trauma Foundation Web
site](http://www.braintrauma.org/site/PageServer?pagename=Guidelines).

Print copies: Available from the Brain Trauma Foundation, 708 Third
Avenue, New York, NY 10017

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI Institute on June 4, 2008.

#### COPYRIGHT STATEMENT

This is a limited license granted to NGC, AHRQ and its agent only. It
may not be assigned, sold, or otherwise transferred. BTF owns the
copyright. For any other permission regarding the use of these
guidelines, please contact the Brain Trauma Foundation.

### DISCLAIMER

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008