|- candidate number||14712|
|- NTR Number||NTR3948|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-apr-2013|
|- Secondary IDs||NL42880.078.13 CCMO|
|- Public Title||Renal fluid responsiveness during oliguria.|
|- Scientific Title||Renal fluid responsiveness in oliguric critically ill patients.|
|- hypothesis||Are there any clinical parameters to help physicians predict whether an oliguric critically ill patient will be fluid responsive, and is it beneficial in terms of outcome?|
|- Healt Condition(s) or Problem(s) studied||Critically ill patients, Oliguria, Fluid therapy|
|- Inclusion criteria||1. 18 years of age or older;|
2. Informed consent;
3. Oliguria for at least 2 consecutive hours;
4. No diuretics administered in the past 3 hours.
|- Exclusion criteria||1. On continuous renal replacement therapy at time of eligibility;|
3. Positive fluid balance ≥ 10 L at time of eligibility;
4. Risk or evidence of pulmonary edema;
5. Risk or evidence of heart failure or coronary illness;
6. pH < 7.25, base excess < -10, or serum chloride > 110 mmol/l;
7. Reasons for fluid therapy other than oliguria;
8. Already included into this study more than 2 times.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mei-2013|
|- planned closingdate||1-aug-2014|
|- Target number of participants||150|
|- Interventions||All subjects will receive an intravenous infusion of 1500 ml of 0.9% saline during 1 hour.|
|- Primary outcome||Fluid responsiveness (urine output to > 0.5 ml/kg/h after fluid therapy). Timepoint: 3 hours.|
|- Secondary outcome||1. Acute kidney injury, Timepoint: 28 days;|
2. All-cause mortality, Timepoint: 28 days;
3. Mechnical ventilation days, Timepoint 28 days;
4. Other complications, Timepoint 28 days.
|- Timepoints||1. T0 = Inclusion, start measurements;|
2. T30(minutes) - T90 = Fluid therapy;
3. T240 = end of measurements;
4. Follow-up until discharge or day 28.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Jasper Bommel, van|
|- CONTACT for SCIENTIFIC QUERIES|| Jasper Bommel, van|
|- Sponsor/Initiator ||Erasmus MC, Department of Intensive care (adults)|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Centre, Department of Intensive Care|
|- Brief summary||Rationale:|
A decline in urine output below 0.5 ml/kg/h (oliguria) puts critically ill patients at risk to develop acute kidney injury, which is associated with a higher mortality and morbidity rate. To attenuate this risk, patients are often given intravenous resuscitation fluids in an attempt to improve diuresis. However these fluids can accumulate when urine output does not improve, resulting in volume overload, edema and subsequent organ damage. Currently there are no clinical parameters to help physicians predict whether an oliguric patient will be fluid responsive, and whether this is beneficial in terms of outcome.
The objective of this study is to identify potential predictors of renal fluid responsiveness and whether fluid responsive patients have more favorable outcomes as opposed to fluid unresponsive patients.
This will be a prospective intervention study.
All critically ill patients admitted to the ICU with oliguria (urine output < 0.5ml/kg/h) for 2 consecutive hours are eligible for inclusion. We will exclude patients with other indications for fluid therapy or unable to safely receive additional fluids.
All patients receive 1500 ml of 0.9% saline within 1 hour. Measurements will be collected before fluid therapy and 2 hours after the end of fluid therapy.
Main study parameters/endpoints:
The main study parameter is renal fluid responsiveness after fluid therapy. Fluid responsiveness is defined as an increase in urine output to ≥ 0.5 ml/kg/h after fluid therapy. Hemodynamic, urine and plasma parameters will be collected to identify possible predictors, and patients will be followed till the 28th day after inclusion or discharge to identify possible differences in renal outcome between groups.
|- Main changes (audit trail)||Planned start date: 1 August 2013 |
Planned closing date: 1 January 2015
|- RECORD||11-apr-2013 - 18-dec-2013|