A Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

May 25, 2010 updated by: Klinikum Ludwigshafen

Phase 4 Study of a Total Balanced Volume Replacement Regimen in Elderly Cardiac Surgery Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • RLP
      • Ludwigshafen, RLP, Germany, 67063
        • Klinikum Ludwigshafen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged >80 years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Total balanced volume replacement regimen consisting of a balanced HES 130/0.42 plus a balanced crystalloid
Drug: Balanced HES 130/0.42
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
Drug: Balanced HES 130/0.42
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
Active Comparator: B
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary endpoint of the study is postoperative renal function
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Other organ function (myocardial function, endothelial function, degree of inflammation)
Time Frame: Postoperative period
Postoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum Ludwigshafen

Investigators

  • Principal Investigator: Joachim Boldt, M.D., Klinikum Ludwigshafen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

December 18, 2007

First Submitted That Met QC Criteria

December 18, 2007

First Posted (Estimate)

December 19, 2007

Study Record Updates

Last Update Posted (Estimate)

May 27, 2010

Last Update Submitted That Met QC Criteria

May 25, 2010

Last Verified

January 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • HES2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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