Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this trial is to assess the beneficial and harmful effects of a restrictive strategy for administration of non-resuscitation fluids in adult patients with septic shock.

Official Title
-----------------
Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients

Conditions
-----------------
Septic Shock

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (≥ 18 years of age) Septic shock according to the Sepsis 3 criteria at any time within 12 hours after ICU admission (suspected or confirmed infection, plasma lactate above 2 mmol/L, and infusion of vasopressor/inotrope to maintain mean arterial pressure of 65mmHg or above after receiving adequate fluid resuscitation [> 1L within 12 h of screening]) and need for vasopressors at the time of screening. Exclusion Criteria: Confirmed or suspected pregnancy Previous inclusion in the trial Screened more than 12 hours after ICU admission

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
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 fluid: discontinued if cumulative fluid balance is positive and patient is not dehydrated Intravenous fluid and enteral water: as needed to correct electrolyte disturbances Enteral nutrition (at least 2 kcal/ml): per local practice Glucose (conc. ≥20%, dose ≤1g/kg/day): may be used as nutrition if enteral feeding not tolerated starting 72h after inclusion. May be started earlier in patients with insulin-dependent diabetes or risk of hypoglycemia per local practice Parenteral nutrition: per local practice Intravenous medications: concentrated according to a predefined protocol Patients with neutral or negative cumulative fluid balance receive maintenance and other fluids so the 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): given at a dose of 1 ml/kg/h unless local protocol states otherwise Glucose: used at maximal concentration of 10% unless local protocol states otherwise. Medications: concentrated per local protocol<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All-cause mortality | 90 days after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications in the ICU | 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 inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days | 
| Days alive and free of mechanical ventilation | Days alive and free of mechanical ventilation | Within 90 days after inclusion | 
| Cognitive function | Cognitive function measured using the Montreal Cognitive Assessment (MoCA) | 6 months after inclusion | 
| Health-Related Quality of Life | Health-Related Quality of Life measured using the European Quality of Life visual analogue scale (EQ-VAS) | 6 months after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
septic shock