Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326112
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-02-26
Brief Title:
Role of Active Deresuscitation After Resuscitation
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
Role of Active Deresuscitation After Resuscitation The RADAR-Canada Pilot Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RADAR-Canada
Brief Summary:
The RADAR-Canada trial is a pilot RCT undertaken to assess the acceptability of compliance with and biologic consequences of a deresuscitation protocol designed to expedite the removal of excess interstitial fluid in patients who remain in a positive fluid balance following admission to an intensive care unit ICU
Detailed Description:
Background Over the course of an acute illness critically ill patients typically receive substantial volumes of intravenous fluids administered for resuscitation maintenance and as diluents for medications A positive fluid balance is associated with adverse clinical outcomes Whether active reversal of a positive fluid balance through fluid restriction and diuresis will improve outcomes is uncertain
Methods The Role of Active Deresuscitation After Resuscitation RADAR trial is a pilot study to determine the feasibility of a larger trial powered for clinically important outcomes the acceptability of a deresuscitation protocol and the impact of a trial on stability of practice patterns RADAR is an open label pilot trial that will recruit 120 patients from 10 to 12 active sites in Canada Eligible patients will be 18 years or older mechanically ventilated 48 hours but in the ICU for less than five days and in a calculated positive fluid balance of three liters Patients will be randomized to either usual care or a deresuscitation protocol incorporating a fluid minimization strategy and diuresis
Results and Discussion Evidence that recruited patients will be managed according to the trial protocol with a withdrawal rate of less than 5 a compliance rate of 75 and a crossover rate of 10 will establish the acceptability of the protocol A mean difference in fluid balance between groups of more than three liters 72 hours after enrolment will establish the feasibility of the protocol Analyses of clinical effects will be secondary analyses Survival to day 90 following randomization will be measured and other clinical measures will provide estimates of rates of key outcomes to inform the design of a definitive adequately powered trial
Methods The Role of Active Deresuscitation After Resuscitation RADAR trial is a pilot study to determine the feasibility of a larger trial powered for clinically important outcomes the acceptability of a deresuscitation protocol and the impact of a trial on stability of practice patterns RADAR is an open label pilot trial that will recruit 120 patients from 10 to 12 active sites in Canada Eligible patients will be 18 years or older mechanically ventilated 48 hours but in the ICU for less than five days and in a calculated positive fluid balance of three liters Patients will be randomized to either usual care or a deresuscitation protocol incorporating a fluid minimization strategy and diuresis
Results and Discussion Evidence that recruited patients will be managed according to the trial protocol with a withdrawal rate of less than 5 a compliance rate of 75 and a crossover rate of 10 will establish the acceptability of the protocol A mean difference in fluid balance between groups of more than three liters 72 hours after enrolment will establish the feasibility of the protocol Analyses of clinical effects will be secondary analyses Survival to day 90 following randomization will be measured and other clinical measures will provide estimates of rates of key outcomes to inform the design of a definitive adequately powered trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None