The Effect of Hydroxyethylstarch 6% 130/0.4 in a Balanced Electrolyte Solution (Volulyte®) Compared to Gelatine (Geloplasma®) on Microvascular Reactivity and Tissue Oxygen Saturation During Haemodilution Measured With Near-infrared Spectroscopy

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-04-30

Brief Summary

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

The aim of this study is to compare 6% hydroxyethyl starch (HES) 130/0.4 in a balanced electrolyte solution (Volulyte®) with modified fluid gelatin (Geloplasma®) as the priming solution for the cardiopulmonary bypass (CPB) circuit. The microvascular reactivity and the effects on tissue (StO2) and cerebral (ScO2) oxygen saturation will be examined using near-infrared spectroscopy (NIRS).

Related Clinical Trials

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

VolulyteTM in Cardiac Surgery

NCT01553617

Heart; Dysfunction Postoperative, 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

Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery

NCT03278548

Hypovolaemia Due to Acute Blood Loss

COMPLETED PHASE4

Priming of Cardiopulmonary Bypass With Hydroxyethyl Starch 130/0.4 or Sodium Chloride 0.9% : Pilot Study in Adult Elective Conventional Cardiac Surgery

NCT02906514

Extracorporeal Circulation Cardiac Surgery

COMPLETED PHASE3

Crystalloids or Colloids for Goal-directed Fluid Therapy With Closed-loop Assistance in Major Surgery

NCT02312999

Surgery

COMPLETED PHASE4

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.

Microvascular Reactivity Tissue Oxygen Saturation

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

DOUBLE

Participants Investigators

Study Groups

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

Volulyte 6%

\- Volulyte 6% (HES 130/0.4 in an isotonic composition). In 1000 ml:

* Maize starch 60 gr. Molar substitution 0.38-0.45. 130000 Da
* Na acetate trihydrate 4.63 gr
* Sodium Chloride 6.02 gr
* Potassium Chloride 0.3 gr
* MgCl 0.3 gr
* Sodium hydroxide-hydrochloric acid \& H2O

Group Type EXPERIMENTAL

Volulyte 6%

Intervention Type DRUG

During elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Volulyte 6% to the cardiopulmonary bypass circuit.

Geloplasma

In 1000 ml:

* Modified fluid gelatin 30 gr
* Sodium Chloride 5.4 gr
* Potassium Chloride 0.37 gr
* MgCl 0.14 gr
* Sodium lactate 3.36 gr

Group Type ACTIVE_COMPARATOR

Geloplasma

Intervention Type DRUG

During elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Geloplasma to the cardiopulmonary bypass circuit.

Interventions

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

Volulyte 6%

During elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Volulyte 6% to the cardiopulmonary bypass circuit.

Intervention Type DRUG

Geloplasma

During elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Geloplasma to the cardiopulmonary bypass circuit.

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

Adult consenting patients scheduled for elective coronary artery bypass grafting surgery on moderately hypothermic (\> 32°C) CPB without blood transfusion. Age ≥ 18 years.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No