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Comparison of HES 130 in Balanced and in Unbalanced Solution

This study has been completed.
Information provided by (Responsible Party):
B. Braun Melsungen AG Identifier:
First received: February 11, 2011
Last updated: January 2, 2012
Last verified: January 2012
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.

Condition Intervention Phase
Decreased and Nonspecific Blood Pressure Disorders and Shock
Drug: 6% HES 130/0.42 in plasma adapted Ringer's solution
Drug: 6% HES 130/0.4 in a saline solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • Maximum difference of the mean arterial blood pressure [ Time Frame: 1 hour ]

Enrollment: 240
Study Start Date: February 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
6% HES 130/0.42 in plasma adapted Ringer's solution (balanced solution)
Drug: 6% HES 130/0.42 in plasma adapted Ringer's solution
60 g/l hydroxyethyl starch 130 dissolved in plasma adapted Ringer's solution (balanced solution)
Active Comparator: 2
HES 130/0.4 in a saline solution
Drug: 6% HES 130/0.4 in a saline solution
60 g/l Hydroxyethyl starch (HES) with a mean molecular weight of 130 kDalton which is dissolved in a saline solution


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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
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Please refer to this study by its identifier: NCT01301469

2 Hospitals
Beijing, China
Guangzhou, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025
Shanghai, China
Sponsors and Collaborators
B. Braun Melsungen AG
Principal Investigator: Buwei Yu, Prof. Dr. Ruijin Hospital
  More Information

Responsible Party: B. Braun Melsungen AG Identifier: NCT01301469     History of Changes
Other Study ID Numbers: HC-G-H-0801
Study First Received: February 11, 2011
Last Updated: January 2, 2012

Additional relevant MeSH terms:
Pharmaceutical Solutions processed this record on April 28, 2017