Effects of hypertonic saline-hydroxyethylstarch solution on extracellular water in cardiac surgery patients

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019352-42-FI

Enrollment

Registered

2010-06-22

Start date

2010-08-19

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fifty adult male patients undergoing coronary bypass surgery will be enrolled in this study. Inclusion criteria are male gender and no need for pulmonary artery catheter (pulmonary hypertension or left ventricular ejection fraction < 40%). Exclusion criterion is chronic hyponatremia and significant renal dysfunction. MedDRA version: 12.1 Level: LLT Classification code 10011078 Term: Coronary artery disease

Interventions

Trade Name: Hyperhaes Product Name: Hyperhaes Product Code: B05AA07 Pharmaceutical Form: Intravenous infusion INN or Proposed INN: NaCl 7.2%/hydroxyethylstarch 200/0.5 Trade Name: Natriumklorid Baxte

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Fifty adult male patients undergoing coronary bypass surgery will be enrolled in this study. Inclusion criteria are male gender and no need for pulmonary artery catheter (pulmonary hypertension or left ventricular ejection fraction =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criterion is chronic hyponatremia and significant renal dysfunction.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary endpoints are the changes in body weight and extracellular water from baseline to the first postoperative morning. ;Secondary Objective: Secondary endpoints are the need of fluids and diuretic medication during the perioperative period.;Primary end point(s): Primary endpoints are the changes in body weight and extracellular water from baseline to the first postoperative morning.	—

Measure

Time frame

Main Objective: Primary endpoints are the changes in body weight and extracellular water from baseline to the first postoperative morning. ;Secondary Objective: Secondary endpoints are the need of fluids and diuretic medication during the perioperative period.;Primary end point(s): Primary endpoints are the changes in body weight and extracellular water from baseline to the first postoperative morning.

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026