Effects of Hypertonic Saline-HES Solution on Extracellular Water in Cardiac Surgery Patients
Effects of Hypertonic Saline-hydroxyethyl Starch Solution on Extracellular Water in Cardiac Surgery Patients
2 other identifiers
interventional
48
1 country
1
Brief Summary
The aim of the study is to describe the effects of hypertonic saline/hydroxyethylstarch solution in comparison to saline solution for 25 + 25 patients undergoing coronary bypass grafting surgery (CABG) using CPB. The study fluid will be given into the venous reservoir of the CPB circuit after aortic declamping. Primary endpoints are the changes in body weight and extracellular water from baseline to the first postoperative morning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 2, 2011
CompletedFirst Posted
Study publicly available on registry
May 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMay 7, 2012
May 1, 2012
1 year
May 2, 2011
May 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in extracellular water from baseline to the first postoperative morning.
Perioperative fluid balance will be assessed by measuring changes in body weight and extracellular water from baseline to the first postoperative morning.
24h
Secondary Outcomes (1)
Need of fluids during the day of surgery.
24h
Study Arms (2)
7.2% NaCl/hydroxyethyl starch
ACTIVE COMPARATOR250 ml of 7.2% NaCl in hydroxyethylstarch (HES 200/0,5) (Hyperhaes®, Fresenius Kabi)
0.9% NaCl
ACTIVE COMPARATOR250 ml of NaCl 0.9% (Natriumklorid Braun 9 mg/ml)
Interventions
250 ml of 7.2% NaCl in hydroxyethylstarch (HES 200/0,5) will be given into the venous reservoir of the cardiopulmonary bypass circuit after aortic declamping.
250 ml of NaCl 0.9% will be given into the venous reservoir of the CPB circuit after aortic declamping.
Eligibility Criteria
You may qualify if:
- male gender and no need for pulmonary artery catheter (pulmonary hypertension or left ventricular ejection fraction \< 40%).
You may not qualify if:
- chronic hyponatremia and significant renal dysfunction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kati Järvelälead
- Finnish Cultural Foundationcollaborator
Study Sites (1)
Tampere University Hospital Heart Center
Tampere, 33521, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kati Järvelä, MD, PhD
Tampere University Hospital Heart Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
May 2, 2011
First Posted
May 5, 2011
Study Start
May 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 7, 2012
Record last verified: 2012-05