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

Shock, Septic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249088
• Other study ID #: REDUSE feasibility trial
• Status: Completed
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: March 27, 2023

Study information

• Verified date: October 2023
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 27, 2023
• Est. primary completion date: September 13, 2022
• 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: 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

Related Conditions & MeSH terms

• Shock
• Shock, Septic

Intervention

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)
• 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

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Halmstad Hospital	Halmstad
Sweden	Helsingborg Hospital	Helsingborg
Sweden	Kristianstad Hospital	Kristianstad
Sweden	Skåne University Hospital, Lund	Lund
Sweden	Skåne University Hospital, Malmö	Malmö
Sweden	Östersund Hospital	Östersund
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Linden A, Fisher J, Lilja G, Olsen MH, Sjovall F, Jungner M, Spangfors M, Samuelsson L, Oras J, Linder A, Unden J, Kander T, Lipcsey M, Nielsen N, Jakobsen JC, Bentzer P. Protocolised reduction of non-resuscitation fluids versus usual care in patients with septic shock (REDUSE): a protocol for a multicentre feasibility trial. BMJ Open. 2023 Feb 28;13(2):e065392. doi: 10.1136/bmjopen-2022-065392. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	All-cause mortality	90 days after inclusion
Other	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 randomization until final discharge from ICU or death, whichever comes first, assessed up to 90 days
Other	Days alive and free of mechanical ventilation	Days alive and free of mechanical ventilation	Within 90 days after inclusion
Other	Cognitive function	Cognitive function measured using MoCA	6 months after inclusion
Other	Health-Related Quality of Life	Health-Related Quality of Life measured using the EQ5D-5L questionnaire	6 months after inclusion
Other	Total volume of non-resuscitation fluids administered	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
Other	Renal function	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
Other	Gastrointestinal function	Days alive with full enteral nutrition	Within 90 days after inclusion
Other	Total volume of resuscitation fluids administered	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
Other	Cumulative fluid balance	Cumulative fluid balance (excluding evaporation)	On day 3 and day 5 after inclusion
Other	Diuretics administered	Daily dose and type of diuretics administered	Within the first five days (days 0-5) after inclusion
Other	Hemodynamic stability	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
Other	Ischemic events	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
Other	GOSE score	Glasgow Outcome Scale Extended (GOSE) score	6 months after inclusion
Primary	Difference in fluid administration	Total difference in litres of administered fluids between groups	Within the first three days after inclusion (days 0-3)
Secondary	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
Secondary	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
Secondary	Inclusion of eligible patients	Fraction of all eligible patients who were randomised and consented	During inclusion
Secondary	Protocol violations	Fraction of patients experiencing at least one protocol violation	Within 90 days after inclusion

External Links

•   Markus Harboe Olsen, et al. Protocolised Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients (REDUSE) - a Statistical Analysis Plan for a Multicentre Feasibility Trial. 3.00, Zenodo, Dec. 2022, doi:10.5281/zenodo.7392132.