Critically Ill, Acute Kidney Injury, Sepsis, Oliguria
Conditions
Keywords
fluid therapy, oliguria, endothelial injury
Brief 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
Detailed description
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.
Interventions
OTHERfollow-up without intervention
OTHERfluid bolus
Sponsors
Central Finland Central Hospital
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in individual mean cumulative urine output (mL/kg/h) | 2 hours after randomization compared to urine output 2 hours preceding randomization | Doubling of the urine output is defined as clinically meaningful response |
Secondary
| Measure | Time frame |
|---|---|
| The difference between groups in the change in individual urine output | 2 hours after randomization compared to urine output 2 hours preceding randomization |
| Duration of consecutive oliguria (urine output <0.5 mL/kg) | 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 | six hours from randomization |
Other
| Measure | Time frame |
|---|---|
| Number of patients receiving renal replacement therapy | during ICU stay(an average of 5 to 7 days or up to 30 days if patient is still in ICU) |
| Number of patients receiving rescue boluses and the number of rescue boluses | study intervention period (i.e. 2 hours) |
| change in heart rate | from randomization to 2 hours post-randomization |
| change in mean arterial pressure | from randomization to 2 hours post-randomization |
| Highest stage of acute kidney injury | 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 | study intervention period (i.e. 2 hours) |
| Number of patients with adverse events | from randomization to next morning |
Countries
Finland
Outcome results
None listed