Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Critically Ill (RESPONSE)
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|ClinicalTrials.gov Identifier: NCT02860572|
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : August 4, 2020
Background: After hypotension, oliguria (urine output less than 0.5 mL/kg/h) was the most common trigger to administer fluid bolus in a multinational practice survey in intensive care. The effect of fluid bolus on cardiovascular variables can be very short-lived among patients in shock suggesting that fluid boluses in the optimization phase are unlikely to improve patient-centered outcomes. Moreover, a growing body of evidence suggests a poor renal response to fluid bolus.
Objective: To investigate, whether fluid bolus - as a standard of care - improves urine output in oliguric patients compared to a non-interventional follow-up approach without fluid bolus.
Design: Investigator-initiated, open, randomized, controlled study
- Intervention group - follow-up without intervention
- Control group - fluid bolus (500mL of balanced crystalloid over 30 minutes)
Randomization: 1:1 stratified according to the site, presence of acute kidney injury, and sepsis
Trial size: 130 patients randomized in 2 ICUs
|Condition or disease||Intervention/treatment||Phase|
|Critically Ill Acute Kidney Injury Sepsis Oliguria||Other: follow-up without intervention Other: fluid bolus||Not Applicable|
The investigators hypothesize that fluid bolus given due to oliguria does not improve urine output in a majority of patients, especially among those with acute kidney injury. Another study hypothesis is that patients receiving fluid bolus will have higher levels of endothelial damage biomarkers.
Intervention group -follow-up without intervention; No intervention to increase the urine output within 2 hours will be done.
Standard group - Fluid bolus group: Patient will receive 500mL of balanced crystalloid intravenously over 30 minutes.
In both groups, if severe hemodynamic instability occurs, a rescue bolus of 500mL over 30 minutes may be given according to the decision of the treating clinician.
In both groups, all other ongoing infusions (nutrition and on-going clear fluids) will be held constant during the 2-hour period. Vasoactive medications, sedation, short-acting insulin, and other medications can be modified according the clinical need. No diuretics during the 2-hour study period are allowed. After two hours from randomization, treating clinician can modify the fluid and drug therapy according to the clinical needs of the patient. All administered fluids will be recorded 6 h from randomization.
Except for the study intervention period of 2 hours, no attempt to control fluid therapy will be done. During the study period, all other aspects of critical care will follow the ICU's standard operating procedures and clinician's prescription.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Optimization Phase of Fluid Therapy in the Critically Ill (the RESPONSE Trial)|
|Actual Study Start Date :||January 10, 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: follow-up without intervention
No intervention to increase the urine output within 2 hours will be done.
Other: follow-up without intervention
Active Comparator: Standard group - fluid bolus
Patient will receive 500mL of balanced crystalloid intravenously over 30 minutes.
Other: fluid bolus
- Change in individual mean cumulative urine output (mL/kg/h) [ Time Frame: 2 hours after randomization compared to urine output 2 hours preceding randomization ]Doubling of the urine output is defined as clinically meaningful response
- The difference between groups in the change in individual urine output [ Time Frame: 2 hours after randomization compared to urine output 2 hours preceding randomization ]
- Duration of consecutive oliguria (urine output <0.5 mL/kg) [ Time Frame: during ICU stay, i.e. as long as urine output stays below 0.5 mL/kg/h while the patient is in the ICU (an average of 5 to 7 days) or until renal replacement therapy is commenced ]
- Cumulative fluid balance [ Time Frame: six hours from randomization ]
- Number of patients receiving rescue boluses and the number of rescue boluses [ Time Frame: study intervention period (i.e. 2 hours) ]
- Highest stage of acute kidney injury [ Time Frame: within 24 hours, 48 hours and during ICU stay (an average of 5 to 7 days or up to 30 days if patient is still in ICU) ]
- Number of patients with one or several protocol violation(s) and number of those per patient [ Time Frame: study intervention period (i.e. 2 hours) ]
- Number of patients with adverse events [ Time Frame: from randomization to next morning ]
- Number of patients receiving renal replacement therapy [ Time Frame: during ICU stay(an average of 5 to 7 days or up to 30 days if patient is still in ICU) ]
- change in mean arterial pressure [ Time Frame: from randomization to 2 hours post-randomization ]
- change in heart rate [ Time Frame: from randomization to 2 hours post-randomization ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860572
|Contact: Suvi Vaara, MD, PhD||050-572968 ext +firstname.lastname@example.org|
|Helsinki University Hospital, Meilahti||Recruiting|
|Helsinki, Uusimaa, Finland, 00290|
|Contact: Suvi Vaara, MD|
|Central Finland Central Hospital||Recruiting|
|Contact: Nina Inkinen, MD email@example.com|
|Principal Investigator: Nina Inkinen, MD|
|Principal Investigator:||Suvi Vaara, MD, PhD||Helsinki University Central Hospital|