Comparison of HES 130 in Balanced and in Unbalanced Solution

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

NCT00576849

Elderly Cardiac Surgery

COMPLETED PHASE4

Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients

NCT03338218

Hypovolemia Due to Acute Blood Loss

COMPLETED PHASE4

Metabolism of Isotonic Versus Hypotonic Maintenance Solutions in Fasting Healthy Adults

NCT02822898

Healthy Adult Volunteers

COMPLETED PHASE4

Mannitol - Potential Role in Hemodialysis Initiation for Reduction of Intra-dialytic Hypotension

NCT01520207

Intra-dialytic Hypotension

COMPLETED PHASE2

Balanced Solution Versus Saline in Intensive Care Study

NCT02875873

Critical Illness Acute Kidney Injury

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Decreased and Nonspecific Blood Pressure Disorders and Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

6% HES 130/0.42 in plasma adapted Ringer's solution (balanced solution)

Group Type EXPERIMENTAL

6% HES 130/0.42 in plasma adapted Ringer's solution

Intervention Type DRUG

60 g/l hydroxyethyl starch 130 dissolved in plasma adapted Ringer's solution (balanced solution)

2

HES 130/0.4 in a saline solution

Group Type ACTIVE_COMPARATOR

6% HES 130/0.4 in a saline solution

Intervention Type DRUG

60 g/l Hydroxyethyl starch (HES) with a mean molecular weight of 130 kDalton which is dissolved in a saline solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No