Survey of Non-resuscitation Fluids in Septic Shock

NCT ID: NCT03438097

Last Updated: 2018-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-08-15

Brief Summary

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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

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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.

Conditions

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Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Skane

OTHER

Sponsor Role lead

Responsible Party

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peter bentzer

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Bentzer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University, Lund, Sweden

Locations

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St Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

ICU Halmstad Hospital

Halmstad, , Sweden

Site Status

ICU Helsingborg Hospital

Helsingborg, , Sweden

Site Status

ICU Kristianstad Hospital

Kristianstad, , Sweden

Site Status

ICU Skane University Hospital

Lund, , Sweden

Site Status

Department of Infections Diseases

Malmo, , Sweden

Site Status

ICU Skane University Hospital

Malmo, , Sweden

Site Status

ICU Ystad Hospital

Ystad, , Sweden

Site Status

Countries

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Canada Sweden

Other Identifiers

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ICU Skane 2017

Identifier Type: -

Identifier Source: org_study_id

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