The objective of this study is to identify potential predictors of renal fluid responsiveness.
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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, and fluid unresponsiveness is defined as persistance of
oliguria after fluid therapy.
Secondary outcome
Hemodynamic, urine and plasma parameters will be collected to identify possible
predictors of renal fluid responsiveness, and patients will be followed till
the 28th day after inclusion or discharge to identify possible differences in
renal outcome between groups.
Background summary
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, and increase
mortality. There are currently no clinical parameters to help physicians
predict whether an oliguric patient will be fluid responsive.
Study objective
The objective of this study is to identify potential predictors of renal fluid
responsiveness.
Study design
This will be a prospective intervention study in which all subjects receive an
intravenous infusion between 500 ml and 1000 ml of 0.9% saline depending on the
clinical situation. Each 500 ml of volume will be infused in 10 to 20 minutes.
All subjects will be measured before treatment and 2 hours after treatment has
ended, and followed until discharge or day 28.
Intervention
All subjects will receive an intravenous infusion between 500 ml and 1000 ml of
0.9% saline. Each 500 ml of volume will be infused in 10 to 20 minutes.
Study burden and risks
Fluid therapy is given as treatment for oliguria and fluids will be
administered through central or peripheral venous catheters inserted beforehand
for standard treatment purposes. Measurements are collected non-invasively and
through already inserted catheters for standard treatment purposes. The
intended infusion volume is safe in this patient category and participation in
this study could lead to direct therapeutic benefit. Incapacitated patients are
included because they are a substantial part of the study population and
excluding them would lead greatly limit the results.
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
's-Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- * 18 years of age
- Informed consent
- Oliguria for at least 2 consecutive hours
- No diuretics administered in the past 3 hours
Exclusion criteria
- On continuous renal replacement therapy at time of eligibility
- Pregnancy
- Positive fluid balance * 10 L at time of eligibility
- Risk or evidence of pulmonary edema
- Risk or evidence of heart failure or coronary illness
- pH < 7.25 or base excess < -10
- Already included into this study more than 2 times.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42880.078.13 |
| OMON | NL-OMON28357 |