Effect of Prime Solution on Fluid Balance After Open Hear... | NCT00797589

Studies
Effect of Prime Solution on Fluid Balance After Open Heart Surgery

NCT00797589

Sponsor

University of Helsinki

Status

Completed

Last Update Posted

Aug 25, 2015Estimated

Enrollment

35Actual

Phase

Phase 4

Conditions

Valve Surgery
Coronary Artery Bypass Grafting

Interventions

HES
Ringer lactate

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Nov 24, 2008

First Submission Date that Met QC Criteria

Nov 24, 2008

First Posted Date

Nov 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2015

Last Update Posted Date

Aug 25, 2015Estimated

Name	Class
B. Braun Melsungen AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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:

Ringer-acetate solution
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ringer lactate	Experimental	Crystalloid solution	Drug: Ringer lactate
HES solution (Tetraspan®)	Experimental	Balanced colloid solution	Drug: HES

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HES	Drug	20ml/kg as prime fluid	HES solution (Tetraspan®)
Ringer lactate

Measure	Description	Time Frame
fluid balance		1 postoperative day

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective combined cardiac surgery

Exclusion Criteria:

Liver failure
Kidney failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raili T Suojaranta-Ylinen, MD, PhD	Helsinki University Central Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital		Helsinki		00029	Finland

Intervention Browse Module

MeSH Terms

ID	Term
D000077325	Ringer's Lactate

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided