Sepsis Clinical Trial
— RESPONSEOfficial 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)
Verified date | December 2020 |
Source | Helsinki University Central Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 130 |
Est. completion date | December 10, 2020 |
Est. primary completion date | December 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Hospital, Meilahti | Helsinki | Uusimaa |
Finland | Central Finland Central Hospital | Jyväskylä |
Lead Sponsor | Collaborator |
---|---|
Helsinki University Central Hospital | Central Finland Central Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of patients receiving rescue boluses and the number of rescue boluses | study intervention period (i.e. 2 hours) | ||
Other | 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) | ||
Other | Number of patients with one or several protocol violation(s) and number of those per patient | study intervention period (i.e. 2 hours) | ||
Other | Number of patients with adverse events | from randomization to next morning | ||
Other | Number of patients receiving renal replacement therapy | during ICU stay(an average of 5 to 7 days or up to 30 days if patient is still in ICU) | ||
Other | change in mean arterial pressure | from randomization to 2 hours post-randomization | ||
Other | change in heart rate | from randomization to 2 hours post-randomization | ||
Primary | 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 | The difference between groups in the change in individual urine output | 2 hours after randomization compared to urine output 2 hours preceding randomization | ||
Secondary | 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 | ||
Secondary | Cumulative fluid balance | six hours from randomization |
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