The aim of this study is to retrieve extra measurements by Nexfin and laboratory testing in the per- and postoperative period. Can the use of Nexfin contribute in the generation of meaningful data to get an idea of the hemodynamic state of theā¦
ID
Source
Brief title
Condition
- Other condition
- Hepatic and hepatobiliary disorders
Synonym
Health condition
Vochthouding in het lichaam tijdens en na een leverresectie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Preoperative
* Weight
* Nexfin parameters: Stroke volume, cardiac output and cardiac index
* 2x 24-hours urine sample for sodium, potassium and creatine excretion
* 1x plasma sample antidiuretic hormone, aldosterone and renin
Intraoperative
* Fluid responsiveness after 250 ml fluid administration
* Nexfin monitoring
* Fluid balance and amount of fluids administered (ml.kg-1.h-1)
Postoperative
* 3 times a day Nexfin parameters: Stroke Volume, Cardiac Output and Cardiac
index. The first measurement is in the morning before mobilization and after 2
minutes mobilization (out of bed; standing of sitting on a chair).
* Daily body weight and ankle & abdominal girth
* 2x 24-hour urine sample with sodium, potassium and creatine excretion
* First 5 days at the ward: daily measurement of electrolytes sodium,
potassium, bicarbonate and chloride.
* Daily measurements of plasma concentrations aldosterone, renin and
antidiuretic hormone will be done before mobilization and after 20 minutes
mobilization.
Secondary outcome
nvt
Background summary
In 2011, thirty-four major liver resections (resection *3 segments) were
performed in the AMC. The outcome of these hemihepatectomies has improved in
the last years because of better surgical techniques and postoperative care.
Nevertheless, there is a large amount of patients who will develop fluid
overload postoperatively.
The stress response to surgery causes anti-diuresis and oliguria. Fluid
administration seems to be a logical step in case of decreased diuresis.
However, after trying to control hypotension with fluid admission, a large
amount of patients develop fluid overload, with the following symptoms: weight
gain, delayed intestinal motility, pleural effusion, ascites and extended
hospital stay.
Therefore, this raises the question whether a decreased diuresis is a
consequence of hypovolemia, which can be controlled by intravenous fluid
administration.
To answer this question we need a more extensive device (in addition to
standard monitoring of blood pressure, heart rate and oxygen saturation) to
monitor the hemodynamic state of the patient per- and post-operatively. We will
use the Nexfin to retrieve supplemental parameters to get a better idea of the
cardiovascular state of the patient. The parameters will be cardiac output,
cardiac index and stroke volume.
Study objective
The aim of this study is to retrieve extra measurements by Nexfin and
laboratory testing in the per- and postoperative period. Can the use of Nexfin
contribute in the generation of meaningful data to get an idea of the
hemodynamic state of the patient during and after surgery?
Study design
15 patients undergoing a major liver resection, will be monitored with the
Nexfin monitor per- and postoperatively. At admission, we will measure the
cardiac output, cardiac index and stroke volume to get a baseline value. During
the operation, every hour a 250 ml fluid challenge will indicate fluid
responsiveness, measured by Nexfin.
Postoperatively, patients will be measured by Nexfin two times a day. The urine
concentrations of sodium, potassium and creatine in a 24-hours urine sample
will be measured twice during hospital stay. Furthermore plasma samples of
aldosterone, renin and ADH will be taken pre and postoperatively. The patients
will receive the standard care. No intervention will be done based on the
Nexfin results.
Study burden and risks
The risks of participating in this trial are low. No extra interventions are
performed, only the Nexfin finger cuff is wrapped around the finger and no
complications of this finger cuff have been reported. The 24-hour urine
collections, plasma samples and nexfin baseline measurements before the
operation can be collected during the standard outpatient clinic visits.
The potential benefits of this study are substantial. The proposed study aims
to do this in a minimally invasive setting that will impose no significant
burden on patients participating in this study.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
patients who will undergo a major hepatectomy
Exclusion criteria
cirrhosis, renal failure, cardiac failure and cardiac arrythmias
Design
Recruitment
Medical products/devices used
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 | NL43476.018.13 |
OMON | NL-OMON20404 |