Non-interventional Follow-up Versus Fluid Bolus in RESPONSE to Oliguria in the Critically Ill
Condition: Critically Ill; Acute Kidney Injury; Sepsis; Oliguria
MeSH terms: Acute Kidney Injury; Oliguria; Critical Illness
Study type: Interventional

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
    

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.
    

Intervention name(s): follow-up without intervention; fluid bolus
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: fluid therapy; oliguria; endothelial injury