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Completed

NCT Number: NCT01301469

Comparison of HES 130 in Balanced and in Unbalanced Solution

The purpose of this study is to evaluate the efficacy of HES 130/0.42 in an electrolyte infusion in comparison to HES 130/0.4 in a sodium chloride infusion.

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Key information

Conditions

Decreased and Nonspecific Blood Pressure Disorders and Shock Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

2 Hospitals, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • Male or female (non pregnant) patients; between 18 and 70 years
  • Elective non-cardiac surgery (except pancreatic or neurological surgery) with an estimated operation duration of 2 hours or longer
  • General anesthesia
  • Voluntary consent

Exclusion:

  • Patients of ASA-class III or IV, Cardiac insufficiency NYHA classes III. IV
  • BMI < 18 or > 29
  • Patients with daily urine output < 1L
  • Patients on hemodialysis
  • Abnormal liver or renal function (i. e. above upper limit of normal range)
  • Abnormal coagulation function (prothrombin time (PT) 3 seconds higher than normal or activated partial thromboplastin time (APTT) 10 seconds higher than normal)
  • Hgb < 10g/dl or HCT < 30%
  • Potassium, sodium or chloride above the upper limit of normal of the laboratory
  • History of diabetes mellitus
  • Known history of a mental or neurological disorder, such as epileptic seizures.
  • History of hypertension and/or taking a beta-receptor blocker or history of atrial fibrillation
  • Patients with known hypersensitivity and with contraindications to HES or any of the excipients

Treatment and study plan

6% HES 130/0.42 in plasma adapted Ringer's solution

Drug

60 g/l hydroxyethyl starch 130 dissolved in plasma adapted Ringer's solution (balanced solution)

6% HES 130/0.4 in a saline solution

Drug

60 g/l Hydroxyethyl starch (HES) with a mean molecular weight of 130 kDalton which is dissolved in a saline solution

Primary outcomes

  1. Maximum difference of the mean arterial blood pressure

    Time frame: 1 hour

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

Prospective, Randomized, Double-blind, Controlled, Multicenter Study on the Efficacy and Safety of HES 130/0. 42 in a Balanced Electrolyte Solution vs a HES 130/0.4 in a Sodium Chloride Solution in Elective Surgery Patients

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 23, 2011
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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