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OpenTrials
Completed

NCT Number: NCT00576849

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.

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Key information

Conditions

Elderly Cardiac Surgery

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinikum Ludwigshafen

Ludwigshafen, RLP, 67063, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged >80 years

Exclusion criteria

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

Treatment and study plan

Balanced HES 130/0.42

Drug

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

6% HES 130/0.4 prepared in saline solution

Drug

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

Primary outcomes

  1. The primary endpoint of the study is postoperative renal function

    Time frame: 28 days

Secondary outcomes

  1. Other organ function (myocardial function, endothelial function, degree of inflammation)

    Time frame: Postoperative period

Sponsors and collaborators

Lead sponsor

Klinikum Ludwigshafen

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 19, 2007
Registry last updated
May 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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