An interventional study of follow-up without intervention and fluid bolus in Critically Ill, Acute Kidney Injury and Sepsis, sponsored by Helsinki University Central Hospital. Completed at 2 sites in Finland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-12-14.
Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Treatment
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
Interventions:
Randomization: 1:1 stratified according to the site, presence of acute kidney injury, and sepsis
Trial size: 130 patients randomized in 2 ICUs
Study hypothesis:
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 description:
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 130 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No intervention to increase the urine output within 2 hours will be done.
Other: follow-up without intervention
Patient will receive 500mL of balanced crystalloid intravenously over 30 minutes.
Other: fluid bolus
Change in individual mean cumulative urine output (mL/kg/h)
Doubling of the urine output is defined as clinically meaningful response
Time frame: 2 hours after randomization compared to urine output 2 hours preceding randomization
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
Plan to share: Yes
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Helsinki University Central Hospital