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

NCT01675453 | Completed Phase 2 Results DMC

• 1 other identifier: ESHHS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Edema

Keywords

Organ dysfunction; Hypertonic solution; Extravascular water; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• 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".

  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 (15)

• Pulmonary Oxygenation

  24 hours

• Oxygen Delivery

  24 hours

• Cardiac Index

  24 hours

• Fluid Balance

  24 hours

• Inflammation Response

  24 hours

Study Arms (2)

7.2% NaCl /hydroxyethyl starch 200/0.5

ACTIVE COMPARATOR

On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)

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

0.9% NaCl

PLACEBO COMPARATOR

On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)

Drug: 0.9% NaCl

Interventions

7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 DRUG

Also known as: HyperHAES

7.2% NaCl /hydroxyethyl starch 200/0.5

0.9% NaCl DRUG

Also known as: Saline

0.9% NaCl

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Novosibirsk Research Institute of Pathology of Circulation

Novosibirsk, Novosibirsk Territory, 630055, Russia

Location

Related Publications (1)

• 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.

  PMID: 24549094 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Edema

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Evgeny Fominskiy
• Organization: Academician EN Meshalkin State Budget Research Institute of Circulation Pathology

evfominskiy@gmail.com

+79139538754

Study Officials

• Vladimir V Lomivorotov, MD, PhD

  Novosibirsk Research Institute of Pathology of Circulation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: August 5, 2012
• First Posted: August 30, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 27, 2016
• Results First Posted: June 19, 2014

Record last verified: 2016-04

Locations

RU (1)