Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Critically Ill (NCT02860572) | Clinical Trial Compass
CompletedNot Applicable
Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Critically Ill
Finland130 participantsStarted 2017-01-10
Plain-language summary
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:
1. Intervention group - follow-up without intervention
2. 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
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age over 18
* Emergency admission to an ICU
* Mean arterial pressure (MAP) \>65 mmHg (with vasopressors if needed) and initial fluid resuscitation for shock/hypovolemia has been given
* Oliguria (urine output less than 0.5mL/kg/h) for at least 2 consecutive hours
Exclusion Criteria:
* Marked fluctuations in hemodynamics within last 2 hours (cardiac arrhythmias, increase in norepinephrine need over 0.2ug/kg/min, need for initiation of inotrope/inodilator)
* Administration of furosemide within last 6 hours
* Chronic kidney disease (estimated pre-critical illness GFR \< 60ml/min/1.73m2)
* Renal replacement therapy
* Among patients with acute kidney injury, urgent indications for commencing renal replacement therapy
* Fluid overload (cumulative fluid accumulation exceeds 10% of baseline body weight)
* Pulmonary edema (bilateral infiltrates in chest x-ray)
* Active bleeding (need for transfusion, platelets, or fresh frozen plasma)
* Suspected or known intra-abdominal hypertension (IAP \>16mmHg)
* Pregnant or lactating
* Expected survival less than 24h
* Obtaining informed consent is not possible/consent is denied
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in individual mean cumulative urine output (mL/kg/h)
Timeframe: 2 hours after randomization compared to urine output 2 hours preceding randomization