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van CCT (UK)

van CCT (UK)

Predicting a renal response to intravenous fluid administration

- candidate number21889
- NTR NumberNTR5126
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-mrt-2015
- Secondary IDsM014-035  Medical Ethical Committee Noord-Holland
- Public TitlePredicting a renal response to intravenous fluid administration
- Scientific TitlePrediction of renal response to intravenous fluid administration by passive leg raising and stroke volume variation.
- hypothesisIt will be investigated whether passive leg raising and stroke volume variations can be used in predicting renal responses to fluid administration. Our hypothesis is that dynamic predictors of cardiac fluid responsiveness can predict an increase in diuresis, rather than static haemodynamic parameters and prerenal biochemical indices as fractional sodium excretion. This can lead to optimal fluid loading in intensive care patients with oliguria to prevent acute kidney injury and fluid overloading.
- Healt Condition(s) or Problem(s) studiedAcute kidney injury, Oliguria
- Inclusion criteria- Age 21 to 80 years
- Mechanically ventilated patients
- Oliguria (diuresis <0.5 ml/kg/hr) after the initial resuscitation period at the ICU
- Exclusion criteria- medical ground
- ethical grounds
- Loss of blood >100 ml per hour
- relevant alterations in inotropic or vasopressor medication.
- Use of clinically relevant diuretics (furosemide, bumetanide, hydrochlorothiazide during the research protocol)
- a known medical history of significant heart failure requiring daily administration of high dose diuretics.
- pulmonary edema.
- pregnancy
- practical drawbacks
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 7-apr-2015
- planned closingdate1-jan-2019
- Target number of participants35
- InterventionsThirty-five patients who are admitted to the Intensive Care Unit with diuresis <0.5 ml/kg/hr after proper initial resuscitation will be measured during a passive leg raising test and subsequently a fluid infusion of 1 L Ringers lactate in 1 hour, which is part of standard treatment. Stroke volume variation (SVV) by Flotrac/Vigileo (Edwards) and static haemodynamic parameters will be monitored during PLR and during fluid infusion. Diuresis an hour before the PLR and up to 2 hours after fluid infusion will be monitored.
- Primary outcomeincrease in diuresis of >10%
- Secondary outcomestatic and dynamic haemodynamic parameters and prerenal biochemical indices
- Timepointst=0, t=60, t=120, t=180 (minutes)
- Trial web site
- status[default]
- CONTACT for SCIENTIFIC QUERIES Annemieke Smorenberg
- Sponsor/Initiator Prof.dr. ABJ Groeneveld
- Funding
(Source(s) of Monetary or Material Support)
Foreest Institute Alkmaar
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD31-mrt-2015 - 22-jul-2018

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