NCT00576849

Brief Summary

A total balanced fluid replacement strategy is a promising concept for correcting hypovolemia. The effects of a balanced fluid management including a new balanced hydroxyethylstarch (HES) in elderly cardiac surgery patients will be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2007

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 27, 2010

Status Verified

January 1, 2009

Enrollment Period

2.4 years

First QC Date

December 18, 2007

Last Update Submit

May 25, 2010

Conditions

ElderlyCardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of the study is postoperative renal function

    28 days

Secondary Outcomes (1)

  • Other organ function (myocardial function, endothelial function, degree of inflammation)

    Postoperative period

Study Arms (2)

A

EXPERIMENTAL

Total balanced volume replacement regimen consisting of a balanced HES 130/0.42 plus a balanced crystalloid

Drug: Balanced HES 130/0.42

B

ACTIVE COMPARATOR

Conventional volume replacement strategy consisting of 6% HES 130/0.4 prepared in saline solution plus Ringer's lactate

Drug: 6% HES 130/0.4 prepared in saline solution

Interventions

Balanced HES 130/0.42DRUG

Volume is administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) was \<60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is \<10 mmHg

A
6% HES 130/0.4 prepared in saline solutionDRUG

Volume will be administered perioperatively and during the first 48 hrs after surgery when mean arterial pressure (MAP) is \<60mmHg and pulmonary capillary wedge pressure (PCWP) or central venous pressure (CVP) is \<10 mmHg

B

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients aged \>80 years

You may not qualify if:

  • Chronic kidney dysfunction requiring dialysis
  • Myocardial infarction within the previous 3 weeks
  • Liver insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Ludwigshafen

Ludwigshafen, RLP, 67063, Germany

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Joachim Boldt, M.D.

    Klinikum Ludwigshafen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

December 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

May 27, 2010

Record last verified: 2009-01

Locations

DE(1)