NCT00797589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

3.7 years

First QC Date

November 24, 2008

Last Update Submit

August 24, 2015

Conditions

Valve SurgeryCoronary Artery Bypass Grafting

Keywords

aorta valvemitral valvecoronary artery bypass grafting surgeryperfusionpriming

Outcome Measures

Primary Outcomes (1)

  • fluid balance

    1 postoperative day

Study Arms (2)

Ringer lactate

EXPERIMENTAL

Crystalloid solution

Drug: Ringer lactate

HES solution (Tetraspan®)

EXPERIMENTAL

Balanced colloid solution

Drug: HES

Interventions

HESDRUG

20ml/kg as prime fluid

HES solution (Tetraspan®)
Ringer lactateDRUG
Ringer lactate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective combined cardiac surgery

You may not qualify if:

  • Liver failure
  • Kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Raili T Suojaranta-Ylinen, MD, PhD

    Helsinki University Central Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 24, 2008

First Posted

November 25, 2008

Study Start

January 1, 2009

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations

FI(1)