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Phase 2 N=40 Randomized Single-blind Prevention

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

Coronary Artery Disease · Edema

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Extravascular Lung Water Index — 9; 8; 9; 8 mL/kg

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 (Drug); 0.9% NaCl (Drug)
Age
Adult, Older Adult · 30+ yrs
Sex
All
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Primary completion
Sep 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Extravascular Lung Water Index
9; 8; 9; 8; 9; 10
SECONDARY
Pulmonary Oxygenation
SECONDARY
Oxygen Delivery
SECONDARY
Cardiac Index
SECONDARY
Fluid Balance
SECONDARY
Inflammation Response
SECONDARY
Endothelial Integrity
SECONDARY
Plasma Na
SECONDARY
Plasma Osmolarity
SECONDARY
Rate of Acute Kidney Injury
SECONDARY
Rate of Hyperchloremic Metabolic Acidosis
SECONDARY
Stroke Volume Index
SECONDARY
Rate of Neurological Complications
SECONDARY
Blood Loss
SECONDARY
Duration of Mechanical Ventilation
SECONDARY
Chloride Loading

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 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%.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01675453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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