NCT03438097

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

February 9, 2018

Last Update Submit

August 26, 2018

Conditions

Keywords

Fluid therapyNon-resuscitation fluidsSeptic shock

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Lack of informed consent (see above)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

St Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

ICU Halmstad Hospital

Halmstad, Sweden

Location

ICU Helsingborg Hospital

Helsingborg, Sweden

Location

ICU Kristianstad Hospital

Kristianstad, Sweden

Location

ICU Skane University Hospital

Lund, Sweden

Location

Department of Infections Diseases

Malmo, Sweden

Location

ICU Skane University Hospital

Malmo, Sweden

Location

ICU Ystad Hospital

Ystad, Sweden

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Peter Bentzer, MD, PhD

    Lund University, Lund, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 19, 2018

Study Start

March 1, 2018

Primary Completion

July 30, 2018

Study Completion

August 15, 2018

Last Updated

August 28, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

On reasonable request

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Study protocol can be shared from March 1st. Clinical Study Report (CSR) can be shared as data analysis is complete.
Access Criteria
On reasonable request

Locations