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NCT Number: NCT02860572

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

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

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Key information

Conditions

Critically Ill Acute Kidney Injury Critical Illness Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Oliguria Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Signs and Symptoms Systemic Inflammatory Response Syndrome Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Meilahti, Helsinki, Uusimaa, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

follow-up without intervention

Other

Fluid bolus

Other

Primary outcomes

  1. Change in individual mean cumulative urine output (mL/kg/h)

    Time frame: 2 hours after randomization compared to urine output 2 hours preceding randomization

    Doubling of the urine output is defined as clinically meaningful response

Secondary outcomes

  1. The difference between groups in the change in individual urine output

    Time frame: 2 hours after randomization compared to urine output 2 hours preceding randomization

  2. Duration of consecutive oliguria (urine output <0.5 mL/kg)

    Time frame: 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

  3. Cumulative fluid balance

    Time frame: six hours from randomization

Other outcomes

  1. Number of patients receiving rescue boluses and the number of rescue boluses

    Time frame: study intervention period (i.e. 2 hours)

  2. Highest stage of acute kidney injury

    Time frame: 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)

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

    Time frame: study intervention period (i.e. 2 hours)

  4. Number of patients with adverse events

    Time frame: from randomization to next morning

  5. Number of patients receiving renal replacement therapy

    Time frame: during ICU stay(an average of 5 to 7 days or up to 30 days if patient is still in ICU)

  6. change in mean arterial pressure

    Time frame: from randomization to 2 hours post-randomization

  7. change in heart rate

    Time frame: from randomization to 2 hours post-randomization

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Central Finland Hospital District

Registry information

Official study title

Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Optimization Phase of Fluid Therapy in the Critically Ill (the RESPONSE Trial)

Acronym: RESPONSE

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 9, 2016
Registry last updated
Dec 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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