Comparison of the Effects of Gelatine Versus Balanced Crystalloid Solution for Volume Therapy

NCT ID: NCT02461329

Last Updated: 2015-06-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-12-31

Brief Summary

The purpose of the study is to determine whether volume therapy with a solution of gelatine has negative impact on coagulation, platelet function, renal function in comparison with crystaloid solution (Ringerfundin).

Detailed Description

After obtaining the research ethics committee approval, 50 patients, undergoing elective surgery for hip replacement will be included. The informed consent must be signed prior to randomization. After arriving to the operation theatre, the patients informed consent and inclusion and exclusion criteria will be reviewed. Afterwards, the patients will be randomized in one of two groups. Prior to the anaesthesia induction, blood for the thrombocyte function test, coagulation tests and thrombelastometry wil be drawn via a metal cannula. A large bore peripheral venous cannula (G18 or more) will be introduced. In case of a ASA status of III and higher based on cardiovascular morbidity an arterial catheter via the radial artery for invasive blood pressure monitoring will be introduced. Urinary catheter will be introduced to monitor intraoperative diuresis. A continuous crystalloid infusion n a dose of 5 ml/kg/hour will be administered for basal fluid substitution. The volume replacement using blinded gelatine/crystalloid solution will be performed via fluid challenge (repeated 250 ml fluid boluses during a 5 minute interval) to hemodynamic targets (increase in blood pressure, decrease in heart rate), in case of a decrease of MAP to 65 mm Hg (16) or to 70 mmHg in preexisting hypertension. The hemodynamic variables before and after fluid challenge will be exactly recorded. In case the patient hemodynamics does dot respond to a fluid challenge, or in case of a drop of blood pressure to less than 55 mmHg, a bolus of 5-10 mg of ephedrine (repeatedly) will be administered. Further recorded variables will be: blood loss (suctioning, sponges), diuresis, number of transfusions administered. Repetitive hemoglobin concentration tests using the HemoCue 201+ device will be performed and an intraoperative blood transfusion trigger of 90 g/l of hemoglobin concentration will be used, 100 g/l in case of a patient with chronic cardiovascular or respiratory disease (5). After reaching the blood loss of 1000 ml, blood samples will be drawn for laboratory hemoglobin concentration and coagulation testing. The trigger for platelet transfusion will be a thrombocyte count of less than 50000 x 109, or sings of platelet dysfunction on thrombelastometry. Tranexamic acid will be administered in case of signs of fibrinolysis on thrombelastometry or in case of life threatening bleeding. At the end of surgery, a second blood sample for platelet function test, thrombelastometry, full blood count and standard coagulation tests will be drawn. The amount of blinded study infusion, continuous crystalloid solution, transfusions and ephedrine administered, diuresis and blood loss will be recorded. Blood urea and creatinine, diuresis, coagulations and full blood count will be recorded postoperatively. Hospital and ICU length of stay, hospital and 90-day mortality will be followed.

Conditions

Hemorrhage, Surgical; Hip Replacement, Total; Thrombocytopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Gelatine solution

Gelofusine will be administrated like "fluid challenge" - 250ml of solution will be infused within 5 minutes in case of hypotension ( mean arterial pressure - MAP below 65 mmHg or below 70mmHg in patient with chronic hypertension disease).

The blood pressure and heart rate before and after fluid challenge will be recorded.

Group Type: EXPERIMENTAL

Gelofusine® B. Braun

Intervention Type: DRUG

Volume therapy by Gelatine solution infusion via intravenous boluses to achieve hemodynamic targets

Balanced Crystaloid solution

Ringerfundin will be administrated like "fluid challenge" - 250ml of solution will be infused within 5 minutes in case of hypotension ( mean arterial pressure - MAP below 65 mmHg or below 70mmHg in patient with chronic hypertension disease).

The blood pressure and heart rate before and after fluid challenge will be recorded.

Group Type: EXPERIMENTAL

Ringerfundin ® B. Braun

Intervention Type: DRUG

Volume therapy by Balanced Crystaloid solution solution infusion via intravenous boluses to achieve hemodynamic targets

Interventions

Gelofusine® B. Braun

Volume therapy by Gelatine solution infusion via intravenous boluses to achieve hemodynamic targets

Intervention Type: DRUG

Ringerfundin ® B. Braun

Volume therapy by Balanced Crystaloid solution solution infusion via intravenous boluses to achieve hemodynamic targets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patient scheduled for elective hip replacement surgery
• age between 19-85 years
• signed informed consent

Exclusion Criteria

• informed consent not signed
• traumatic hip fracture
• anemia (hemoglobin level < 100 g/l)
• allergy to study drug and/or multiple allergies
• chronic heart failure with LVEF < 30%
• shock states
• coagulopathy
• thrombocytopenia
• thrombocytopathy
• chronic kidney disease with oliguria
• chronic antiplatelet drug medications

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IBA - Masaryk University Institute of biostatistics and analyses

UNKNOWN

Sponsor Role: collaborator

Kratochvil Milan, MD

OTHER

Sponsor Role: lead

Responsible Party

Kratochvil Milan, MD

Research coordinator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Milan Kratochvil, MD

Role: PRINCIPAL_INVESTIGATOR

FN Brno

Milan Kratochvil, MD

Role: STUDY_DIRECTOR

FN Brno

Roman Gál, Prof, MD, Ph.D

Role: STUDY_CHAIR

Fn Brno

Central Contacts

Milan Kratochvil, MD

Role: CONTACT

mkratochvil@fnbrno.cz

+420532232009

Jozef Klučka, MD

Role: CONTACT

jozefklucka@seznam.cz

+420775467052

Other Identifiers

FN-Brno

Identifier Type: -

Identifier Source: org_study_id