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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01301469

Enrollment

240

Registered

2011-02-23

Start date

2011-02-28

Completion date

2011-07-31

Last updated

2012-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decreased and Nonspecific Blood Pressure Disorders and Shock

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.

Interventions

DRUG6% 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)

DRUG6% 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026