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

Coronary Artery Disease Clinical Trial

— ESHHS  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675453
• Other study ID #: ESHHS
• Status: Completed
• Phase: Phase 2
• First received: August 5, 2012
• Last updated: May 18, 2014
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: May 2014
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Edema
• Myocardial Ischemia

Intervention

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

• 0.9% NaCl

Locations

Country	Name	City	State
Russian Federation	Novosibirsk Research Institute of Pathology of Circulation	Novosibirsk	Novosibirsk territory

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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; POD 1	No
Secondary	Pulmonary Oxygenation	Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure.	24 hours	No
Secondary	Oxygen Delivery	Oxygen delivery index (DO2I) will be used to assess this outcome measure.	24 hours	No
Secondary	Cardiac Index		24 hours	No
Secondary	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.	24 hours	No
Secondary	Inflammation Response	Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure.	24 hours	No
Secondary	Endothelial Integrity	Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure.	24 hours	No
Secondary	Plasma Na		24 hours	Yes
Secondary	Plasma Osmolarity		24 hours	Yes
Secondary	Rate of Acute Kidney Injury	serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure.	48 hours	Yes
Secondary	Rate of Hyperchloremic Metabolic Acidosis	blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure.	24 hours	Yes
Secondary	Stroke Volume Index		24 hours	No
Secondary	Rate of Neurological Complications	Delirium, clinically diagnosed stroke, and encephalopathy.	24 hours	Yes
Secondary	Blood Loss	Bleeding from chest tubes	24 hours	Yes
Secondary	Duration of Mechanical Ventilation		24 hours	No
Secondary	Chloride Loading	The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay	24 h	Yes