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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
40
Novosibirsk Research Institute of Pathology of Circulation
Novosibirsk, Novosibirsk Territory, Russia
Extravascular Lung Water Index
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".
Time frame: 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
Pulmonary Oxygenation
Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure.
Time frame: 24 hours
Oxygen Delivery
Oxygen delivery index (DO2I) will be used to assess this outcome measure.
Time frame: 24 hours
Cardiac Index
Time frame: 24 hours
Fluid Balance
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.
Time frame: 24 hours
Inflammation Response
Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure.
Time frame: 24 hours
Endothelial Integrity
Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure.
Time frame: 24 hours
Plasma Na
Time frame: 24 hours
Plasma Osmolarity
Time frame: 24 hours
Rate of Acute Kidney Injury
serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure.
Time frame: 48 hours
Rate of Hyperchloremic Metabolic Acidosis
blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure.
Time frame: 24 hours
Stroke Volume Index
Time frame: 24 hours
Rate of Neurological Complications
Delirium, clinically diagnosed stroke, and encephalopathy.
Time frame: 24 hours
Blood Loss
Bleeding from chest tubes
Time frame: 24 hours
Duration of Mechanical Ventilation
Time frame: 24 hours
Chloride Loading
The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay
Time frame: 24 h
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