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Comparison of HES 130 in Balanced and in Unbalanced Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG
ClinicalTrials.gov Identifier:
NCT01301469
First received: February 11, 2011
Last updated: January 2, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Shock
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01301469

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

No publications provided

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01301469     History of Changes
Other Study ID Numbers: HC-G-H-0801
Study First Received: February 11, 2011
Last Updated: January 2, 2012
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013