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

Septic Shock Clinical Trial

— REDUSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06140147
• Other study ID #: REDUSE
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: July 1, 2028

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: Peter Bentzer
• Phone: +46 42-4061111
• Email: Peter.Bentzer[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1850
• Est. completion date: July 1, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Other:
• Protocolised reduction of non-resuscitation fluids
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)
• 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): 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

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Halmstad Hospital	Halmstad
Sweden	Helsingborg Hospital	Helsingborg
Sweden	Skåne University Hospital, Lund	Lund
Sweden	Skåne University Hospital, Malmö	Malmö
Sweden	Östersund Hospital	Östersund
Sweden	Södersjukhuset	Stockholm
Sweden	University Hospital of Umeå	Umeå
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital-free days	Hospital-free days	Within 90 days after inclusion
Other	Vasopressor-free days	Vasopressor-free days	Within 90 days after inclusion
Other	Renal replacement therapy (RRT)-free days	RRT-free days	Within 90 days after inclusion
Other	Major adverse kidney events (MAKE)	The composite of death, new receipt of renal replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value =200% of the baseline value)	90 days after inclusion
Other	Cumulative dose of diuretics	Cumulative dose of diuretics (defined daily doses according to the World Health Organization [WHO])	5 days after inclusion
Other	Glasgow Outcome Scale Extended (GOSE) score	GOSE score	6 months after inclusion
Other	Health-Related Quality of Life	Health-Related Quality of Life measured using the European Quality of Life visual 5-dimension 5-level scale (EQ-5D-5L) questionnaire	6 months after inclusion
Other	Health and disability	Health and disability measured using the WHO Disability Assessment Schedule (WHODAS) 2.0 (12 item version)	6 months after inclusion
Other	Modified Fatigue Impact Scale (MFIS)	MFIS questionnaire (full-length version)	6 months after inclusion
Other	Mortality	All-cause mortality	12 months after inclusion
Other	Number of days in the ICU	Number of days in the ICU	Within 90 days of inclusion
Other	Hypoglycaemia	Number of patients with moderate hypoglycaemia (glucose 3.9 - 2.3 mmol/l) and severe hypoglycaemia (glucose = 2.2 mmol/l)	From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Other	Hypernatremia	Number of patients with hypernatremia (sodium > 159 mmol/L)	From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Other	Acid-base disturbances	Number of patients with acid-base disturbances (hyperchloremic acidosis [pH < 7.15 and plasma Cl- > 115] or metabolic alkalosis [pH > 7.59 and S-BE > 9])	From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Other	Central venous catheter-related complications	Number of patients with any central venous catheter related complications that could potentially be related to concentrated drugs given in the intervention group (for example, thrombosis, stenosis, malfunction, and infections)	From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Primary	Mortality	All-cause mortality	90 days after inclusion
Secondary	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
Secondary	Mechanical ventilation-free days	Mechanical ventilation-free days	Within 90 days after inclusion
Secondary	Cognitive function	Cognitive function measured using the Montreal Cognitive Assessment (MoCA)	6 months after inclusion
Secondary	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