Effect of Prime Solution on Fluid Balance After Open Heart Surgery

NCT ID: NCT00797589

Last Updated: 2015-08-25

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-09-30

Brief Summary

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The use of Tetraspan® as prime solution can reduce fluid extravasation after perfusion versus Ringer acetate. Plasma-adapted HES-solutions produce also less acidosis.

Detailed Description

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Fifty patients scheduled for elective primary and single cardiac surgery include in this prospective study. Patients with preoperative coagulation disorders, or renal or hepatic failure, are excluded.

Before admission to the operation theatre, the patients allocate in random order to receive one of the following solutions during the extracorporeal circulation:

1. Ringer-acetate solution
2. 6% HES solution (Tetraspan®) During the 1 postoperative day we register hemodynamic changes, fluid balance, fluid extravasation, plasma ion concentration, modified thromboelastography, and kidney function.

Conditions

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Valve Surgery Coronary Artery Bypass Grafting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Ringer lactate

Crystalloid solution

Group Type EXPERIMENTAL

Ringer lactate

Intervention Type DRUG

HES solution (Tetraspan®)

Balanced colloid solution

Group Type EXPERIMENTAL

HES

Intervention Type DRUG

20ml/kg as prime fluid

Interventions

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HES

20ml/kg as prime fluid

Intervention Type DRUG

Ringer lactate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective combined cardiac surgery

Exclusion Criteria

* Liver failure
* Kidney failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B. Braun Melsungen AG

INDUSTRY

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Alexey Schramko

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raili T Suojaranta-Ylinen, MD, PhD

Role: STUDY_CHAIR

Helsinki University Central Hospital

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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2008-001225-34

Identifier Type: -

Identifier Source: org_study_id

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