Phase 2
N=40
The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.
Coronary Artery Disease · Edema
Bottom Line
View on ClinicalTrials.gov: NCT01675453 ↗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
| Outcome | Result | p-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%.
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.