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## Complete Summary

#### GUIDELINE TITLE

Evidence-based guidelines for nutritional support of the critically ill:
results of a Bi-National Guideline Development Conference.

#### BIBLIOGRAPHIC SOURCE(S)

Doig GS. Evidence-based guidelines for nutritional support of the
critically ill: results of a bi-national guideline development
conference. Carlton (Australia): Australian and New Zealand Intensive
Care Society (ANZICS); 2005. 282 p. \[387 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

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

### SCOPE

#### DISEASE/CONDITION(S)

Critical illness that would normally or usually require care in an
intensive care unit

#### GUIDELINE CATEGORY

Assessment of Therapeutic Effectiveness\
Management

#### CLINICAL SPECIALTY

Critical Care\
Nutrition

#### INTENDED USERS

Advanced Practice Nurses\
Dietitians\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To develop or update and validate an evidence-based feeding guideline
for critically ill patients

#### TARGET POPULATION

Critically ill patients who would normally or usually be cared for in an
intensive care unit for two days or longer

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Enteral nutrition vs. standard care

2.  Early enteral nutrition (\<24 hours) vs. delayed enteral nutrition

3.  Parenteral nutrition compared to standard care

4.  Parenteral nutrition compared to enteral nutrition

5.  Parenteral nutrition compared to early enteral nutrition (\<24
    hours)

6.  Parenteral nutrition compared to delayed enteral nutrition

7.  Gastric vs. post-pyloric enteral nutrition.

8.  Use of prokinetics

9.  Enteral nutrition and parenteral nutrition compared to enteral
    nutrition alone

10. Enteral nutrition supplemented with arginine compared to standard
    enteral nutrition *(considered but no recommendation made)*

11. Enteral nutrition supplemented with arginine vs parenteral nutrition
    *(considered but no recommendation made)*

12. Parenteral nutrition with glutamine vs. standard parenteral
    nutrition

13. Enteral nutrition with glutamine vs. standard enteral nutrition

14. Hypocaloric (Dose) of parenteral nutrition

15. Parenteral nutrition composition - Branched Chain Amino Acid (BCAA)
    content: High BCAA (\>40%) vs. Low (\<27%) content *(considered but
    no recommendation made)*

#### MAJOR OUTCOMES CONSIDERED

Mortality

### 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

An extensive literature search was conducted for controlled trials of
feeding interventions conducted in critically ill patients. Terms were
also specified to identify methodologically rigorous guidelines,
overviews, and meta-analyses. A complete listing of search terms is
available from the guideline developer on request. On-line searching of
Medline and EMBASE, and hand searching the reference lists of retrieved
review papers, was undertaken. Recognised experts and industry were
contacted for additional references. The final close-out date for this
search process was April 2003.

Medline was searched using the PubMed search engine from 1966 to April
2003. EMBASE was searched using OVID from 1980 to April 2003.

The reference lists of several review articles were hand searched. For a
complete list see the original guideline document.

Although the literature search itself was not limited to the
identification of non-English language publications, the review process
focused on English language publications only. Similarly, only studies
published full-paper format that could be adequately critically
appraised were considered for review.

#### NUMBER OF SOURCE DOCUMENTS

The Medline/EMBASE search retrieved 2,287 abstracts. Independent review
of all abstracts identified approximately 465 papers that may have been
controlled trials or review papers on the topic of interest. All 465
papers were retrieved. Review of these 465 papers identified 337 primary
studies that evaluated feeding interventions. Detailed review or
critical appraisal of the 337 identified primary studies revealed 111
primary feeding studies that were conducted in critically ill patients
and reported clinically meaningful outcomes. All 111 were appraised in
detail to determine validity.

In addition the literature search identified one evidence-based
guideline for nutritional support in the intensive care unit that had
previously been validated in a cluster randomised trial.

#### 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

**[Levels of Evidence]{.underline}**

**Level I**: adequately powered\* (low false +ve or false -ve), well
conducted trials

**Level II**: small, under-powered (high false +ve and false -ve), well
conducted trials

**Level III\*\***: non-randomised concurrent (contemporary) controls

**Level IV\*\***: non-randomised historical controls

**Level V\*\***: case series without controls

\*The guideline developers defined power as a measure of the probability
that a clinical trial will detect a treatment effect of a given
magnitude (X), under the assumption that the treatment effect actually
exists. To qualify as a Level I trial (adequately powered), the
trialists must have established that it was plausible to assume that the
treatment effect of magnitude X actually existed. Data from earlier
trials is the best way to establish the plausibility of the magnitude of
the expected treatment effect (Halpern, S.D., Karlawish, J.H., and
Berlin, J.A. \[2002\]. The continuing unethical conduct of underpowered
clinical trials. *JAMA* 288, 358-362).

\*\* These Levels of Evidence were not considered at this guideline
conference.

#### METHODS USED TO ANALYZE THE EVIDENCE

Meta-Analysis of Randomized Controlled Trials\
Review of Published Meta-Analyses\
Systematic Review

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

Fixed effects meta-analysis using the odds ratio metric. Heterogeneity
was assessed using the I^2^ method.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus (Consensus Development Conference)

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

The evidence-based guidelines development meeting was conducted in
accordance with the methodology outlined in Browman\'s Practice
Guideline Development Cycle (PGDC). The PGDC is an explicit process that
has been validated for the generation, implementation, and evaluation of
evidence-based clinical practice guidelines (see Table 1 in the original
guideline document). The PGDC process is employed by Cancer Care Ontario
([www.cancercare.on.ca](http://www.cancercare.on.ca/)) to develop
patient and practitioner-level evidence-based guidelines.

In short, the PGDC requires the generation of a series of *systematic
reviews* covering optimally effective approaches to the diagnosis and
treatment of a specific condition. These reviews are synthesised from
the best available evidence and then graded to result in *evidence-based
recommendations* (EBRs). The EBRs are formally augmented with expert
opinion and customised to local settings before being implemented as
guidelines.

In advance of the meeting: an extensive literature review was
undertaken; all randomized controlled trials were critically appraised
for methodological quality; overviews of focused clinical questions were
compiled leading to evidence-based recommendations for optimally
effective techniques; reprints and summaries of each trial were
circulated.

At the meeting; evidence-based recommendations were reviewed and
ratified and guideline statements compiled.

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

**[Grades of Recommendations]{.underline}**

**A+**: More than one well conducted, adequately powered randomized
controlled trial (RCT) with consistent results between studies (no
heterogeneity), Level of Evidence Required: I

**A**: At least one well conducted, adequately powered RCT, Level of
Evidence Required: I

**A-**: More than one well conducted, adequately powered RCT with
inconsistent results (heterogeneity) between studies, Level of Evidence
Required: I

**B+**: More than one well conducted RCT with consistent results between
studies, Level of Evidence Required: II

**B**: At least one well conducted RCT, Level of Evidence Required: II

**B-**: More than one well conducted RCT with inconsistent results
(heterogeneity) between studies, Level of Evidence Required: II

#### COST ANALYSIS

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

#### METHOD OF GUIDELINE VALIDATION

Clinical Validation-Pilot Testing

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The final ratified guideline was evaluated in a 27 hospital cluster
randomised trial conducted in Australia and New Zealand.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The levels of evidence (I-IV) and grades of recommendations identifying
the type of supporting evidence (A+, A, A-, B+, B, B-) are defined at
the end of the \"Major Recommendations\" field.

The following evidence-based recommendations were ratified at the
guideline development conference.

-   **Enteral Nutrition (EN) in preference to Standard Care (nothing by
    mouth \[NPO\]), Grade B+ recommendation**

> 5 Level II randomized controlled trials (RCTs). Ratified by positive
> meta-analysis and validated evidence-based guideline (Algorithms for
> Critical Care Enteral and Parenteral Therapy \[ACCEPT\]).

-   **Early EN (\<24 hours) in preference to delayed EN, Grade B
    recommendation**

> 3 Level II RCTs. Ratified by validated evidence-based guideline
> (ACCEPT).

-   **Parenteral Nutrition (PN) in preference to Standard Care
    (Intravenous \[IV\] Glucose), Grade B recommendation**

> 5 Level II RCTs. Ratified by validated evidence-based guideline
> (ACCEPT).

-   **Early EN (\<24 hours) in preference to PN, Grade B
    recommendation**

> 6 Level II RCTs. Ratified by validated evidence-based guideline
> (ACCEPT).

-   **Early PN (**

> 5 Level II RCTs. Ratified by positive meta-analysis and validated
> evidence-based guideline (ACCEPT). The results of the meta-analysis
> supporting this evidence-based recommendation (EBR) have been
> published elsewhere.

-   **Post-pyloric feeding when gastric feeding not tolerated, Grade B
    recommendation**

> 8 Level II RCTs. Ratified by validated evidence-based guideline
> (ACCEPT).

-   **Use of prokinetics when gastric feeding not tolerated, Grade B
    recommendation**

> 5 Level II RCTs. Ratified by validated evidence-based guideline
> (ACCEPT).

-   **EN supplemented with PN if 80% of goals not met with EN alone
    (after attempts at postpyloric feeding and use of prokinetics) by 72
    hours, Grade B recommendation**

> 4 Level II RCTs. Ratified by validated evidence-based guideline
> (ACCEPT).

-   **PN with glutamine vs. standard PN, Grade B- recommendation**

> 4 Level II RCTs. Ratified by meta-analysis, **heterogeneity present**.
>
> Glutamine *may* be beneficial in select patients. To identify which
> patients *may* benefit, each constituent RCT should be reviewed and
> clinical judgement should be exercised.

-   **Management of diarrhoea, Grade B recommendation**

> Ratified by validated evidence-based guideline (ACCEPT).

-   **Gastric residual values and tolerance, Level B evidence**

> Ratified by validated evidence-based guideline (ACCEPT).

**[Definitions]{.underline}**:

**Levels of Evidence**

**Level I**: adequately powered\* (low false +ve or false -ve), well
conducted trials

**Level II**: small, under-powered (high false +ve and false -ve), well
conducted trials

**Level III\*\***: non-randomised concurrent (contemporary) controls

**Level IV\*\***: non-randomised historical controls

**Level V\*\***: case series without controls

\*The guideline developers defined power as a measure of the probability
that a clinical trial will detect a treatment effect of a given
magnitude (X), under the assumption that the treatment effect actually
exists. To qualify as a Level I trial (adequately powered), the
trialists must have established that it was plausible to assume that the
treatment effect of magnitude X actually existed. Data from earlier
trials is the best way to establish the plausibility of the magnitude of
the expected treatment effect (Halpern, S.D., Karlawish, J.H., and
Berlin, J.A. \[2002\]. The continuing unethical conduct of underpowered
clinical trials. *JAMA* 288, 358-362).

\*\* These Levels of Evidence were not considered at this guideline
conference.

**Grades of Recommendations**

**A+**: More than one well conducted, adequately powered randomized
controlled trial (RCT) with consistent results between studies (no
heterogeneity), Level of Evidence Required: I

**A**: At least one well conducted, adequately powered RCT, Level of
Evidence Required: I

**A-**: More than one well conducted, adequately powered RCT with
inconsistent results (heterogeneity) between studies, Level of Evidence
Required: I

**B+**: More than one well conducted RCT with consistent results between
studies, Level of Evidence Required: II

**B**: At least one well conducted RCT, Level of Evidence Required: II

**B-**: More than one well conducted RCT with inconsistent results
(heterogeneity) between studies, Level of Evidence Required: II

#### CLINICAL ALGORITHM(S)

Algorithms are provided in the original guideline document for:

-   Intensive care unit feeding

-   Addressing tube feeding associated diarrhea

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

When evaluated in a cluster randomised trial including 499 patients from
14 hospitals, the adoption of this guideline resulted in a 10% reduction
in mortality (p = 0.058) and an average decrease in hospital stay of 10
days (p = 0.003).

#### POTENTIAL HARMS

Not stated

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Expected intensive care unit (ICU) length of stay less than 2 days.
Expected or scheduled return to oral intake in less than 2 days.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

Some of the critical appraisal summaries included in the original
guideline document in the section titled \"randomized controlled trials
(RCTs) excluded due to major methodological flaws\" may appear
incomplete. In these randomized controlled trials, the major flaw that
was detected was considered so significant that it precluded the trial
from consideration in the guidelines development process and thus the
appraisal of other issues was considered unnecessary.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

A detailed implementation strategy is available from the guideline
developer (see the \"Availability of Companion Documents\" field in this
summary).

#### IMPLEMENTATION TOOLS

Clinical Algorithm\
Slide Presentation\
Wall Poster

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

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

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Doig GS. Evidence-based guidelines for nutritional support of the
critically ill: results of a bi-national guideline development
conference. Carlton (Australia): Australian and New Zealand Intensive
Care Society (ANZICS); 2005. 282 p. \[387 references\]

#### ADAPTATION

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

#### DATE RELEASED

2005

#### GUIDELINE DEVELOPER(S)

Australian & New Zealand Intensive Care Society - Private Nonprofit
Organization

#### SOURCE(S) OF FUNDING

Australian & New Zealand Intensive Care Foundation

#### GUIDELINE COMMITTEE

ANZICS CTG Feeding Investigators Group

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Primary Authors*: Gordon S. Doig, Senior Lecturer in Intensive Care,
Northern Clinical School, University of Sydney; Fiona Simpson, Clinical
Associate Lecturer, Human Nutrition Unit, School of Molecular and
Microbial Biosciences, University of Sydney

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[Evidence Based Decision-Making Web
site](http://www.evidencebased.net/files/EBGforNutSupportofICUpts.pdf).

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Doig GS. Evidence-based guidelines for nutritional support of the
    critically ill: results of a bi-national guideline development
    conference. Implementation strategies. 2005. 81 p. Available in
    Portable Document Format (PDF) from the [Evidence Based
    Decision-Making Web
    site](http://www.evidencebased.net/files/ImplementationStrategy.pdf).

-   Evidence-based guidelines for nutritional support of the critically
    ill: results of a bi-national guideline development conference.
    Clinical algorithms. 2005. 2 p. Available in Portable Document
    Format (PDF) from the [Evidence Based Decision-Making Web
    site](http://www.evidencebased.net/files/2sidedletter.pdf).

-   Evidence-based guidelines for nutritional support of the critically
    ill: results of a bi-national guideline development conference. Wall
    poster. 2005. 1 p. Available in Portable Document Format (PDF) from
    the [Evidence Based Decision-Making Web
    site](http://www.evidencebased.net/files/poster.pdf).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on October 11, 2005. The
information was verified by the guideline developer on October 18, 2005.

#### COPYRIGHT STATEMENT

This summary is based on the original guideline, which is subject to the
guideline developer\'s copyright restrictions.

### DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008