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

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ClinicalTrials.gov Identifier: NCT02860572
Recruitment Status : Recruiting
First Posted : August 9, 2016
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Central Finland Central Hospital
Information provided by (Responsible Party):
Suvi Vaara, Helsinki University Central Hospital

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


Condition or disease Intervention/treatment Phase
Critically Ill Acute Kidney Injury Sepsis Oliguria Other: follow-up without intervention Other: fluid bolus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: follow-up without intervention
No intervention to increase the urine output within 2 hours will be done.
Other: follow-up without intervention
Active Comparator: Standard group - fluid bolus
Patient will receive 500mL of balanced crystalloid intravenously over 30 minutes.
Other: fluid bolus



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860572


Contacts
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Contact: Suvi Vaara, MD, PhD 050-572968 ext +358 suvi.vaara@hus.fi

Locations
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Finland
Helsinki University Hospital, Meilahti Recruiting
Helsinki, Uusimaa, Finland, 00290
Contact: Suvi Vaara, MD         
Central Finland Central Hospital Recruiting
Jyväskylä, Finland
Contact: Nina Inkinen, MD       nina.inkinen@ksshp.fi   
Principal Investigator: Nina Inkinen, MD         
Sponsors and Collaborators
Helsinki University Central Hospital
Central Finland Central Hospital
Investigators
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Principal Investigator: Suvi Vaara, MD, PhD Helsinki University Central Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Suvi Vaara, MD, PhD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02860572    
Other Study ID Numbers: 200/13/03/02/16
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Suvi Vaara, Helsinki University Central Hospital:
fluid therapy
oliguria
endothelial injury
Additional relevant MeSH terms:
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Acute Kidney Injury
Oliguria
Critical Illness
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Urination Disorders
Urological Manifestations