The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.

Phase 2

Completed

Conditions: Coronary Artery Disease
Edema

Interventions: Drug: 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5
Drug: 0.9% NaCl

Registration Number: NCT01675453

Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary: The 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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%.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7.2% NaCl /hydroxyethyl starch 200/0.5	7.2% NaCl plus 6% hydroxyethyl starch 200/0.5	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)
0.9% NaCl	0.9% NaCl	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)

Primary Outcome Measures

Name	Time	Method
Extravascular Lung Water Index	baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1	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".

Secondary Outcome Measures

Name	Time	Method
Pulmonary Oxygenation	24 hours	Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure.
Oxygen Delivery	24 hours	Oxygen delivery index (DO2I) will be used to assess this outcome measure.
Cardiac Index	24 hours
Fluid Balance	24 hours	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.
Inflammation Response	24 hours	Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure.
Endothelial Integrity	24 hours	Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure.
Plasma Na	24 hours
Plasma Osmolarity	24 hours
Rate of Acute Kidney Injury	48 hours	serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure.
Rate of Hyperchloremic Metabolic Acidosis	24 hours	blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure.
Stroke Volume Index	24 hours
Rate of Neurological Complications	24 hours	Delirium, clinically diagnosed stroke, and encephalopathy.
Blood Loss	24 hours	Bleeding from chest tubes
Duration of Mechanical Ventilation	24 hours
Chloride Loading	24 h	The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay