Comparison of HES 130 in Balanced and in Unbalanced Solution

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

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.

Study Overview

• Status: Completed
• Conditions: Decreased and Nonspecific Blood Pressure Disorders and Shock
• Intervention / Treatment: Drug: 6% HES 130/0.42 in plasma adapted Ringer's solution; Drug: 6% HES 130/0.4 in a saline solution

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • 2 Hospitals
  • Guangzhou, China
    • Hospital
  • Shanghai, China, 200025
    • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai, China
    • Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum difference of the mean arterial blood pressure	1 hour

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Buwei Yu, Prof. Dr., Ruijin Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: February 11, 2011
• First Submitted That Met QC Criteria: February 22, 2011
• First Posted (ESTIMATE): February 23, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 5, 2012
• Last Update Submitted That Met QC Criteria: January 2, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: HC-G-H-0801