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Comparison of HES 130 in Balanced and in Unbalanced Solution

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ClinicalTrials.gov Identifier: NCT01301469
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):
B. Braun Melsungen AG

Brief Summary:
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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : February 2011
Primary Completion Date : July 2011
Study Completion Date : July 2011

Arm Intervention/treatment
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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01301469     History of Changes
Other Study ID Numbers: HC-G-H-0801
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Pharmaceutical Solutions