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Completed

NCT Number: NCT00469716

Hypertonic Saline-hetastarch in Cardiac Surgery

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Section for thoracic and cardiovascular surgery, Haukeland University Hospital

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Primary outcomes

  1. Cardiac output, intrathoracic blood volume, extravascular lung water, global enddiastolic volume

    Time frame: 12 hours

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

Infusion of Hypertonic Saline-hetastarch in Cardiac Surgery

Acronym: HH

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 4, 2007
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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