The objective of the study is to investigate if predictors of cardiac responsiveness are able to predict a renal response to fluid administration in oliguria.
ID
Source
Brief title
Condition
- Other condition
- Renal disorders (excl nephropathies)
Synonym
Health condition
Vloeistofovervulling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study parameters are: SVV, stroke volume (SV) and cardiac output (CO),
static haemodynamic parameters including SvO2, lactate, diuresis and urinary
indices.
Secondary outcome
For the substudy fluid in the lungs will be assessed by looking at artefacts
with lung ultrasound.
Background summary
Oliguria is a symptom of volume depletion and a risk for developing acute
kidney injury. Acute kidney injury is associated with higher mortality and
morbidity in Intensive Care patients. The common treatment is fluid
administration and restore possible fluid deficiency, with the risk of fluid
overload and edema, particularly when the kidney is damages and non-responsive
to fluids. Dynamic parameters as stroke volume variation and its response to
passive leg raising (PLR) seems able to predict cardiac fluid responsiveness.
Their ability to predict an increase in diuresis to fluid administration
however is unknown.
Study objective
The objective of the study is to investigate if predictors of cardiac
responsiveness are able to predict a renal response to fluid administration in
oliguria.
Study design
This prospective clinical trial concerns the evaluation of well-known
predictors of intravascular volume and cardiac responsiveness with renal
responsiveness to fluid administration.
Thirty-five patients who are admitted to the Intensive Care Unit with diuresis
<0.5 ml/kg/hr after proper initial resuscitation will be analysed 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.
Study burden and risks
Before fluid therapy, patients will be connected to Flotrac/Vigileo (Edwards)
by the radial arterial catheter already in place in ICU patients for SVV
analysis. No additional placement of catheters is needed.
1.0 liter of Ringers* lactate is the first choice in volume replacement and has
been shown to be safe in healthy individuals, does not raise lactate levels and
may only give small and transient changes in osmolality. As part of the
standard therapy to oliguria, 1.0 liter of Ringers* lactate will be
administered in 1 hour, however now in a protocolled manner to analyse this
standard treatment.
The results may help to construct a protocol to treat and reverse oliguria and
prevent harmful fluid overloading in critically ill patients.
Lung ultrasound is part of standard care on the intensive care and carries no
riks.
Wilhelminalaan 12
Alkmaar 1815JD
NL
Wilhelminalaan 12
Alkmaar 1815JD
NL
Listed location countries
Age
Inclusion criteria
- Mechanically ventilated patients of both gender
- Age 21 years and under 80 years of age
- admitted to the intensive care unit (ICU) with oliguria (<0.5 ml/kg/hr) after the initial resuscitation period at the ICU defined by: no or low increase (less than 25%) in vasopressor medication in the past 2 hour before inclusion and fluid administration less than 500 ml Ringers* lactate per hour.
Exclusion criteria
- medical grounds: the physician requires to deviate from current protocol to adequately treat other life threatening events.
- ethical grounds: e.g. pre-terminal illness
- Loss of blood >100 ml per hour
- relevant alterations in inotropic or vasopressor medication.
- Use of clinically relevant diuretics (furosemide, bumetanide, hydrochloorthiazide during the research protocol)
- a known medical history of significant heart failure requiring daily administration of high dose diuretics.
- pulmonary edema.
- pregnancy
- practical drawbacks
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50343.094.14 |