Title
The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.
The Efficacy and Safety of 7.2% NaCl Plus 6% Hydroxyethyl 200/0.5 in Patients Scheduled for First-time Coronary Artery Bypass Grafting With Cardiopulmonary Bypass.
Phase
Phase 2Lead Sponsor
Moscow State UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Edema Coronary Artery DiseaseIntervention/Treatment
sodium chloride hydroxyethyl starch ...Study Participants
40The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac surgery patients. Systemic inflammatory response initiated by CPB through releasing of several mediators lead to altered endothelial integrity and in consequence the leakage of proteins and fluids from the intravascular to the interstitial compartment is occurred. Increased capillary permeability and decreased colloid osmotic pressure were shown to play a key role for fluid shift and increasing of extravascular water. Further tissue edema can result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to adverse outcomes.
Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid shift from the intracellular and the interstitial spaces of tissue into the intravascular compartment.
The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass.
On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)
Inclusion Criteria: patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass Exclusion Criteria: age >70 years body mass index <18 and >35 kg/m2 left ventricular ejection fraction <40% myocardial infarction <6 months before surgery stroke or transient ischemic attack <12 months before surgery diabetes mellitus glomerular filtration rate <90 mL/min emergency surgery hematocrit <30%.
| Event Type | Organ System | Event Term |
|---|
Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to "Predicted Body Weight".
Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure.
Outcome Measure Data Not Reported
Oxygen delivery index (DO2I) will be used to assess this outcome measure.
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Net fluid balance at the end of surgery equals the sum of all infusions minus the urine output. Net fluid balance at postoperative day 1 equals the sum of all infusions minus the urine output and blood loss.
Outcome Measure Data Not Reported
Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure.
Outcome Measure Data Not Reported
Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure.
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure.
Outcome Measure Data Not Reported
blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure.
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
Delirium, clinically diagnosed stroke, and encephalopathy.
Outcome Measure Data Not Reported
Bleeding from chest tubes
Outcome Measure Data Not Reported
The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay
Outcome Measure Data Not Reported
Outcome Measure Data Not Reported
