Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Critically Ill
NCT ID: NCT02860572
Last Updated: 2020-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
130 participants
INTERVENTIONAL
2017-01-10
2020-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
follow-up without intervention
No intervention to increase the urine output within 2 hours will be done.
follow-up without intervention
Standard group - fluid bolus
Patient will receive 500mL of balanced crystalloid intravenously over 30 minutes.
fluid bolus
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
follow-up without intervention
fluid bolus
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Central Finland Central Hospital
UNKNOWN
Helsinki University Central Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Suvi Vaara
MD, PhD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Suvi Vaara, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Helsinki University Hospital, Meilahti
Helsinki, Uusimaa, Finland
Central Finland Central Hospital
Jyväskylä, , Finland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
200/13/03/02/16
Identifier Type: -
Identifier Source: org_study_id