Survey of Non-resuscitation Fluids in Septic Shock (SURF)

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Peter Bentzer, MD, PhD, Lund University, Lund, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): August 15, 2018

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 15, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 26, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Septic shock; Fluid therapy; Non-resuscitation fluids
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: ICU Skane 2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On reasonable request
• IPD Sharing Time Frame: Study protocol can be shared from March 1st. Clinical Study Report (CSR) can be shared as data analysis is complete.
• IPD Sharing Access Criteria: On reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No