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Comparison of HES 130 in Balanced and in Unbalanced Solution

NCT01301469 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2012-01-05

No results posted yet for this study

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.

Conditions

  • Decreased and Nonspecific Blood Pressure Disorders and Shock

Interventions

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)

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

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • Buwei Yu, Prof. Dr. · Ruijin Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01301469 on ClinicalTrials.gov