Protocolized Reduction of Non-resuscitation Fluids vs Usual Care in Septic Shock Feasibility Trial

December 4, 2023 updated by: Region Skane

Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients: A Multicentre Feasibility Trial

The objectives of this feasibility trial are to assess the efficacy and feasibility of methods and procedures of a protocol purposed to compare a reduction of administration of non-resuscitation fluids to usual care in patients with septic shock.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
      • Halmstad, Sweden
        • Halmstad Hospital
      • Helsingborg, Sweden
        • Helsingborg Hospital
      • Kristianstad, Sweden
        • Kristianstad Hospital
      • Lund, Sweden
        • Skåne University Hospital, Lund
      • Malmö, Sweden
        • Skåne University Hospital, Malmö
      • Uppsala, Sweden
        • Uppsala University Hospital
      • Östersund, Sweden
        • Östersund Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult (≥ 18 years of age)
  • Septic shock according to the Sepsis 3 criteria: suspected or confirmed infection AND infusion of vasopressor/inotrope to maintain mean arterial pressure of 65 mmHg or above despite adequate fluid resuscitation AND lactate of 2 mmol/L or above at any time following ICU admission when there was a simultaneous need for vasopressor/inotrope.
  • Inclusion within 12 hours after ICU admission.

Exclusion Criteria:

  • Confirmed or suspected pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Protocolised reduction of non-resuscitation fluids
Participants receive non-resuscitation fluids according to a pre-defined protocol starting within two hours of randomization. The intervention is continued for the duration of the ICU admission up to a maximum of 90 days.
Other: Protocolised reduction of non-resuscitation fluids
  • Maintenance fluids are discontinued in participants with positive cumulative fluid balance who are not dehydrated
  • Intravenous fluid and enteral water are given as needed to correct electrolyte disturbances
  • Enteral nutrition with energy density of at least 2 kcal/ml is administered according to local practice
  • Starting 72 hours after inclusion, glucose at a concentration of at least 20% and a maximal dose of 1g/kg/day may be used as nutrition if enteral feeding is not tolerated. Glucose at this dose or lower may be started earlier in patients with insulin dependent diabetes if enteral feeding is not tolerated and local protocol mandates this
  • Parenteral nutrition is administered according to local protocol
  • Intravenous medications are concentrated according to a predefined protocol
  • Patients with neutral or negative cumulative fluid balance receive maintenance and other fluids such that total dose of fluids covers the daily need of water (about 1ml/kg/h)
Other: Usual Care
Participants receive non-resuscitation fluids according to local routines.
Other: Usual care

Participants receive non-resuscitation fluids according to local routines, with the following stipulations:

  • Maintenance fluids (crystalloids and/or glucose and/or enteral water) are given at a dose of 1 ml/kg/h unless local protocol states otherwise
  • Glucose is used at maximal concentration of 10% unless local protocol states otherwise.
  • Medications are concentrated according to local protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in fluid administration
Time Frame: Within the first three days after inclusion (days 0-3)
Total difference in litres of administered fluids between groups
Within the first three days after inclusion (days 0-3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of participants with sufficient clinical outcome data
Time Frame: Within 90 days after inclusion
Fraction of randomised patients with sufficient data for the following clinical outcomes: all-cause mortality, days alive and free of mechanical ventilation, acute kidney injury, and ischemic events in the ICU (cerebral, cardiac, intestinal or limb ischemia)
Within 90 days after inclusion
Proportion of participants assessed by EQ5D-5L and MoCA
Time Frame: 6 months after inclusion
Fraction of surviving randomized patients who were assessed by European Quality of Life-5 Dimensions 5- Level questionnaire (EQ5D-5L) and The Montreal Cognitive Assessment (MoCA)
6 months after inclusion
Inclusion of eligible patients
Time Frame: During inclusion
Fraction of all eligible patients who were randomised and consented
During inclusion
Protocol violations
Time Frame: Within 90 days after inclusion
Fraction of patients experiencing at least one protocol violation
Within 90 days after inclusion

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days after inclusion
All-cause mortality
90 days after inclusion
Complications in the ICU
Time Frame: from randomization until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Number of patients with one or more of the following complications in the ICU: cerebral, cardiac, intestinal or limb ischemia, or any acute kidney injury
from randomization until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Days alive and free of mechanical ventilation
Time Frame: Within 90 days after inclusion
Days alive and free of mechanical ventilation
Within 90 days after inclusion
Cognitive function
Time Frame: 6 months after inclusion
Cognitive function measured using MoCA
6 months after inclusion
Health-Related Quality of Life
Time Frame: 6 months after inclusion
Health-Related Quality of Life measured using the EQ5D-5L questionnaire
6 months after inclusion
Total volume of non-resuscitation fluids administered
Time Frame: Within the first three days (days 0-3) and within the first five days (days 0-5) after inclusion
Total volume of non-resuscitation fluids administered
Within the first three days (days 0-3) and within the first five days (days 0-5) after inclusion
Renal function
Time Frame: Within 90 days after inclusion
Acute kidney injury stages according to Kidney Disease Improving Global Outcomes [KDIGO] criteria, urea, and days alive and free of renal replacement therapy [RRT]
Within 90 days after inclusion
Gastrointestinal function
Time Frame: Within 90 days after inclusion
Days alive with full enteral nutrition
Within 90 days after inclusion
Total volume of resuscitation fluids administered
Time Frame: Within the first three days (days 0-3) and within the first five days (days 0-5) after inclusion
Total volume of resuscitation fluids administered
Within the first three days (days 0-3) and within the first five days (days 0-5) after inclusion
Cumulative fluid balance
Time Frame: On day 3 and day 5 after inclusion
Cumulative fluid balance (excluding evaporation)
On day 3 and day 5 after inclusion
Diuretics administered
Time Frame: Within the first five days (days 0-5) after inclusion
Daily dose and type of diuretics administered
Within the first five days (days 0-5) after inclusion
Hemodynamic stability
Time Frame: Within the first five days (days 0-5) after inclusion
Daily highest dose of noradrenaline, daily lactate, and cardiovascular sequential organ failure assessment [SOFA] score
Within the first five days (days 0-5) after inclusion
Ischemic events
Time Frame: from randomization until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Number of patients with one or more ischemic events while in the ICU (cerebral, cardiac, intestinal or limb ischemia)
from randomization until final discharge from ICU or death, whichever comes first, assessed up to 90 days
GOSE score
Time Frame: 6 months after inclusion
Glasgow Outcome Scale Extended (GOSE) score
6 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Skane

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Bentzer, MD, PhD, Region Skane

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 13, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REDUSE feasibility trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Beginning 9 months after publication of the main report of this trial individual de-identified data will be available for sharing with researchers who provide a methodologically sound proposal as judged by the steering committee. To gain access, data requestors will need to sign a data access agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings