Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Critically Ill

NCT02860572 | Completed

• 1 other identifier: 200/13/03/02/16
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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. 1.Intervention group - follow-up without intervention
2. 2.Control group - fluid bolus (500mL of balanced crystalloid over 30 minutes)

Conditions

Critically Ill; Acute Kidney Injury; Sepsis; Oliguria

Keywords

fluid therapy; oliguria; endothelial injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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 Outcomes (7)

• 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)

• Number of patients with one or several protocol violation(s) and number of those per patient

  study intervention period (i.e. 2 hours)

Study Arms (2)

follow-up without intervention

EXPERIMENTAL

No intervention to increase the urine output within 2 hours will be done.

Other: follow-up without intervention

Standard group - fluid bolus

ACTIVE COMPARATOR

Patient will receive 500mL of balanced crystalloid intravenously over 30 minutes.

Other: fluid bolus

Interventions

follow-up without intervention OTHER

follow-up without intervention

fluid bolus OTHER

Standard group - fluid bolus

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Central Finland Central Hospital: collaborator

Study Sites (2)

Helsinki University Hospital, Meilahti

Helsinki, Uusimaa, 00290, Finland

Location

Central Finland Central Hospital

Jyväskylä, Finland

Location

Related Publications (3)

• 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.

  PMID: 39242877 DERIVED

• 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.

  PMID: 36550559 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.

  PMID: 32270496 DERIVED

MeSH Terms

Conditions

Critical Illness; Acute Kidney Injury; Sepsis; Oliguria

Interventions

Methods

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Suvi Vaara, MD, PhD

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 9, 2016
• Study Start: January 10, 2017
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

FI (2)