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

Study Overview
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Brief Summary
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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.

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

Conditions
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Shock, Septic

Intervention / Treatment
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* Other: Protocolised reduction of non-resuscitation fluids
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protocolised reduction of non-resuscitation fluids<br>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<br>* 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)<br>|
| Other: Usual Care<br>Participants receive non-resuscitation fluids according to local routines. | Other: Usual care<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in fluid administration | Total difference in litres of administered fluids between groups | Within the first three days after inclusion (days 0-3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with sufficient clinical outcome data | 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 | 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 | Fraction of all eligible patients who were randomised and consented | During inclusion | 
| Protocol violations | Fraction of patients experiencing at least one protocol violation | Within 90 days after inclusion |