Clinical trial NCT03438097: Survey of Non-resuscitation Fluids in Septic Shock
Official title: Survey of Non-resuscitation Fluids in Septic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Keywords: Fluid therapy
Non-resuscitation fluids
Septic shock
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients admitted with septic shock during a 4 month period in ICUs in Sweden and in British Columbia, Canada. A maximum of 30 patients per centre will be recruited.

Brief summary: The objective of this study is to survey the type and the amount of non-resuscitation fluids that patients with septic shock receives during their first 5 days of ICU admission.

Detailed description: Background: Several studies indicate that a large part of the fluid intake in intensive care patients consists of fluids that are given for indications other than volume expansion. However, the type of non-resuscitation fluids that hemodynamically unstable ICU patients receive has not been well characterized.

Methods: A multicenter observational cohort study. Baseline data including, sex, age, physiological data at admission, source of sepsis, illness severity, and ICU and hospital mortality will be collected.

Fluids administered during the first five days of ICU admission will be registered. Fluids used as vehicle to administer drugs will be regarded as non-resuscitation fluids and will be characterized in detail. All glucose solutions will be regarded as non-resuscitation fluids. Crystalloids delivered at a rate of \< 5 ml/kg/h will be considered as non-resuscitation fluids. Parenteral nutrition will be regarded as non-resuscitation fluids. Crystalloids delivered at a rate of ≥ 5 ml/kg/h will be considered to be resuscitation fluids. Blood products and colloids will be regarded as resuscitation fluids.

Eligibility criteria: Inclusion Criteria:

* Septic shock per SEPSIS-3 criteria within 24 hrs of ICU admission
* Informed consent from patient or next of kin if required by local ethical review Board

Exclusion Criteria:

• Lack of informed consent (see above)

Primary outcomes:
measure: Type, indication and volume of fluids given to septic shock patients for other reasons than circulatory support.
timeFrame: First five days in ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Halmstad
country: Sweden
facility: ICU Halmstad Hospital
city: Helsingborg
country: Sweden
facility: ICU Helsingborg Hospital
city: Kristianstad
country: Sweden
facility: ICU Kristianstad Hospital
city: Lund
country: Sweden
facility: ICU Skane University Hospital
city: Malmö
country: Sweden
facility: Department of Infections Diseases
city: Malmö
country: Sweden
facility: ICU Skane University Hospital
city: Ystad
country: Sweden
facility: ICU Ystad Hospital
Study officials:
affiliation: Lund University, Lund, Sweden
name: Peter Bentzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: