Survey of Non-resuscitation Fluids in Septic Shock

Septic Shock Clinical Trial

— SURF  

Official title:

Survey of Non-resuscitation Fluids in Septic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438097
• Other study ID #: ICU Skane 2017
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: August 15, 2018

Study information

• Verified date: August 2018
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 15, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Locations

Country	Name	City	State
Canada	St Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Sweden	ICU Halmstad Hospital	Halmstad
Sweden	ICU Helsingborg Hospital	Helsingborg
Sweden	ICU Kristianstad Hospital	Kristianstad
Sweden	ICU Skane University Hospital	Lund
Sweden	Department of Infections Diseases	Malmö
Sweden	ICU Skane University Hospital	Malmö
Sweden	ICU Ystad Hospital	Ystad

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Countries where clinical trial is conducted

Canada,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type, indication and volume of fluids given to septic shock patients for other reasons than circulatory support.	Type of fluid is defined as either 0.9% normal saline, glucose, Ringers acetate/lactate, enteral nutrition, parenteral nutrition or sterile water.; Indication is defined as vehicle, nutrition, maintenance or other. Volume will be reported in ml.	First five days in ICU