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Hypertonic Saline-hetastarch in Cardiac Surgery

Infusion of Hypertonic Saline-hetastarch in Cardiac Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00469716
Acronym
HH
Enrollment
50
Registered
2007-05-04
Start date
2007-04-30
Completion date
2008-05-31
Last updated
2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cardiorespiratory Failure

Keywords

Fluid balance, respiratory function, cardiac function, inflammation, Cardiopulmonary bypass

Brief summary

Cardiopulmonary bypass(CPB) is associated with increased fluid extravasation and edema formation. A continuous infusion of a mixture of hypertonic saline/hydroxyethyl starch (HSH)during CPB reduced fluid extravasation and total fluid gain during bypass in an animal model. We hypothesize that a continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory functions in patients undergoing coronary artery bypass with CPB.

Detailed description

Cardiopulmonary bypass (CPB) is associated with fluid overload and edema formation occasionally resulting in vital organ dysfunction affecting heart, respiratory system , gastrointestinal tract and brain. Hyperosmolar/hyperoncotic preparations (HSH/HSD) have been used in cardiac surgery essentially with the aim to mobilize fluid excess and improve postoperative cardiorespiratory function.Most studies dealing with the administration of HSD or HSH during and after CPB, have used protocols recommended for treatment of severe hypovolemia and shock, that is 4 mL/kg as a bolus, given within minutes.In animal experiments we have used HSD or HSH, 1 mL/kg/h to a total dose of 4 mL/kg during CPB. The use of HSH/HSD reduced the total fluid gain about 50 % and resulted in significantly lower content of tissue water in vital organs as heart and lungs. In the actual clinical trial we hypothesize that a continuous infusion of HSH will reduce fluid load and increase hemodynamic and respiratory functions monitored with the PiCCO system in patients undergoing coronary artery bypass with CPB.

Interventions

DRUGHypertonic saline (7.2%) hetastarch (6 %)(200/0.5)

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients scheduled for elective coronary artery bypass graft surgery

Exclusion criteria

* Age \<18 years or \> 75 years * BMI\< 18 or \> 30 * Left ventricular ejection fraction \< 40% * Emergency operations * Additional valvular diseases * Impaired renal function * Serum sodium\> 145 mmol/l * Hematocrit\< 30% * Use of clopidogrel the last 5 days

Design outcomes

Primary

MeasureTime frame
Cardiac output, intrathoracic blood volume, extravascular lung water, global enddiastolic volume12 hours

Secondary

MeasureTime frame
Time to extubation, fluid balance, paO2/FiO2- ratio, frequency of atrial fibrillation, cytokines, time to ICU-release and hospital release.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026