The primary objective is to assess the effect a resuscitation strategy using balanced solutions versus unbalanced solutions on regional and microvascular perfusion relative to global hemodynamics in intensive care patients following elective cardiac…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Hemodynamische instabiliteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Renal perfusion: δa.u./δCI
- δa.u. (arbitrary units) obtained by CEUS, expressed in percentages
- δCI (cardiac index) obtained by swan ganz, expressed in CO/m2 = (mL
blood/minute)/m2
Hepatic perfusion: δPDR/δCI
- δPDR (plasma disappearance rate) obtained by LiMON, expressed in
percentage/minute.
- Distribution and clearance of infused fluids by kinetic model analysis,
estimating Vc, k10, k12, and k21 using hemoglobin sampling during and after
infusion.
Secondary outcome
Not applicable.
Background summary
Recently studies have shown a beneficiary effect of using balanced fluid
resuscitation unbalanced fluid resuscitation (the main difference being the
chloride concentration) on the complications following kidney transplant, open
abdominal surgery and help prevent AKI in ICU patients.
Animal test studies showed an overall better micro- and macro-vascular renal
circulation.
The SPLIT Trials did not find an in-/decreased risk between the two different
fluid resuscitation strategies. Further studies including specific ICU patient
group were recommended.
In our pilot study we set out to investigate if balanced or unbalanced fluid
strategies have a different effect on the renal and hepatic perfusion in
patients following cardiac surgery. To investigate the difference in renal
perfusion we will be using Contrast Enhanced UltraSound (CEUS). To assess the
hepatic perfusion we will use indocyanine green and the LiMON system. The
primary endpoint will be the change in cardiac index (CI) in association with
the change in renal and hepatic perfusion. Each patient will serve as his/her
own control by being administered unbalanced and balanced fluids. See protocol.
Study objective
The primary objective is to assess the effect a resuscitation strategy using
balanced solutions versus unbalanced solutions on regional and microvascular
perfusion relative to global hemodynamics in intensive care patients following
elective cardiac surgery. See protocol.
Study design
Randomised controlled clinical crossover pilot study. See protocol.
Intervention
Administration of 2 x 250 mL routinely used balanced or unbalanced fluids. See
protocol.
Study burden and risks
The use of the SonoVue contrast agent is associated with: headache, numbness,
vertigo, dysosmia, flushing, sore throat, nausea, abdominal discomfort, itch,
backache and hyperglycaemia (1:100 - 1:1000 patients); insomnia, pain or
pressure in the ENT-region, blurred vision, hypotension, overall sensation of
pain, pain on the chest, fatigue and allergic reactions ranging from erythema
to anaphylaxis (1:1000-1:10.000 patients). The use of ICG is associated with
rare cases of anaphylaxis. Especially in patients know with a iodine allery,
iodine is a excipient in indocyanine green. See protocol.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Age > 18 years
ICU admission following elective cardiac surgery
Undergoing cardiac output monitoring with a Pulmonary Artery Catheter
Need for fluid resuscitation as determined by the treating intensivist
Exclusion criteria
Pregnancy
Renal failure (eGFR < 60ml/min/1.73 m2 or on RRT)
Iodide allergy
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-000495-22-NL |
| CCMO | NL56705.029.16 |