Clinical trial NCT01675453: The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Edema
Keywords: Organ dysfunction
Hypertonic solution
Extravascular water
Cardiopulmonary Bypass
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2012-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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%.

Primary outcomes:
measure: Extravascular Lung Water Index
timeFrame: 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
Secondary outcomes:
measure: Pulmonary Oxygenation
timeFrame: 24 hours
measure: Oxygen Delivery
timeFrame: 24 hours
measure: Cardiac Index
timeFrame: 24 hours
measure: Fluid Balance
timeFrame: 24 hours
measure: Inflammation Response
timeFrame: 24 hours
measure: Endothelial Integrity
timeFrame: 24 hours
measure: Plasma Na
timeFrame: 24 hours
measure: Plasma Osmolarity
timeFrame: 24 hours
measure: Rate of Acute Kidney Injury
timeFrame: 48 hours
measure: Rate of Hyperchloremic Metabolic Acidosis
timeFrame: 24 hours
measure: Stroke Volume Index
timeFrame: 24 hours
measure: Rate of Neurological Complications
timeFrame: 24 hours
measure: Blood Loss
timeFrame: 24 hours
measure: Duration of Mechanical Ventilation
timeFrame: 24 hours
measure: Chloride Loading
timeFrame: 24 h
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Pathology of Circulation
state: Novosibirsk territory
Study officials:
affiliation: Novosibirsk Research Institute of Pathology of Circulation
name: Vladimir V Lomivorotov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lomivorotov VV, Fominskiy EV, Efremov SM, Nepomniashchikh VA, Lomivorotov VN, Chernyavskiy AM, Shilova AN, Karaskov AM. Infusion of 7.2% NaCl/6% hydroxyethyl starch 200/0.5 in on-pump coronary artery bypass surgery patients: a randomized, single-blind pilot study. Shock. 2014 Mar;41(3):193-9. doi: 10.1097/SHK.0000000000000087.