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| Name | Class |
|---|---|
| Central Finland Hospital District | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| follow-up without intervention | Experimental | No intervention to increase the urine output within 2 hours will be done. |
|
| Standard group - fluid bolus | Active Comparator | Patient will receive 500mL of balanced crystalloid intravenously over 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| follow-up without intervention | Other |
| ||
| fluid bolus |
| Measure | Description | Time Frame |
|---|---|---|
| Change in individual mean cumulative urine output (mL/kg/h) | Doubling of the urine output is defined as clinically meaningful response | 2 hours after randomization compared to urine output 2 hours preceding randomization |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients receiving rescue boluses and the number of rescue boluses | study intervention period (i.e. 2 hours) | |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suvi Vaara, MD, PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital, Meilahti | Helsinki | Uusimaa | 00290 | Finland | ||
| Central Finland Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39242877 | Derived | Serlo M, Inkinen N, Lakkisto P, Valkonen M, Pulkkinen A, Selander T, Pettila V, Vaara ST. Fluid bolus increases plasma hyaluronan concentration compared to follow-up strategy without a bolus in oliguric intensive care unit patients. Sci Rep. 2024 Sep 6;14(1):20808. doi: 10.1038/s41598-024-71670-2. | |
| 36550559 | Derived |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D058186 | Acute Kidney Injury |
| D018805 | Sepsis |
| D009846 | Oliguria |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Other |
|
| Cumulative fluid balance | six hours from randomization |
| 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 |
| 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) |
| change in mean arterial pressure | from randomization to 2 hours post-randomization |
| change in heart rate | from randomization to 2 hours post-randomization |
| Jyväskylä |
| Finland |
| Inkinen N, Pettila V, Valkonen M, Serlo M, Backlund M, Hastbacka J, Pulkkinen A, Selander T, Vaara ST. Non-interventional follow-up versus fluid bolus in RESPONSE to oliguria in hemodynamically stable critically ill patients: a randomized controlled pilot trial. Crit Care. 2022 Dec 22;26(1):401. doi: 10.1186/s13054-022-04283-8. |
| 32270496 | Derived | Inkinen N, Selander T, Pettila V, Valkonen M, Backlund M, Wennervirta J, Pulkkinen A, Hastbacka J, Vaara ST. Noninterventional follow-up vs fluid bolus in RESPONSE to oliguria-The RESPONSE trial protocol and statistical analysis plan. Acta Anaesthesiol Scand. 2020 Sep;64(8):1210-1217. doi: 10.1111/aas.13599. Epub 2020 Apr 28. |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |