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

NCT05249088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-12-11

No results posted yet for this study

Summary

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.

Conditions

  • Shock, Septic

Interventions

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, 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

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Principal Investigators

  • Peter Bentzer, MD, PhD · Region Skåne

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-09-13
Completion
2023-03-27

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05249088 on ClinicalTrials.gov