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Completed

NCT Number: NCT01401283

GDT by Cardiac Index Trending Via a Radial Arterial Line in General Surgery

This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients

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Key information

Conditions

Reduction of Length of Hospitality Stay, Reduction of Perioperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

About this study

This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients Clinical outcome of patients undergoing major abdominal surgery is explored in two different groups. In one group hemodynamic management is guided by the internal standard of the anesthesiological department. In the other group fluid management is goal directed by by continuous cardiac index trending via a radial arterial line and pulse pressure variation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • major abdominal surgery
  • duration of surgery > 2 hours

Exclusion criteria

  • age < 18 years
  • scheduled postoperative icu treatment

Treatment and study plan

measurement of cardiac output and pulse pressure variation

Device

hemodynamic optimization according to cardiac index and pulse pressure variation

Primary outcomes

  1. Postoperative Complications

    Time frame: Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days

    Categories of postoperative complications: Infection (respiratory, abdominal, UTI, wound), Respiratory (prolonged need for ventilation), Cardiovascular (edema, arrythmia, hypotension, AMI, stroke), Abdominal (constipation), Renal (urine output <500ml/d, ARF)

Secondary outcomes

  1. Hospital Stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days

    length of stay in the postoperative care unit, length of hospital stay

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Northern State Medical University
  • Szeged University
  • University of Kiel
  • University of Valencia
  • University of Witten/Herdecke

Registry information

Official study title

Multi-center, Prospective, Randomized Outcome Study Comparing Continuous Cardiac Index Trending Via a Radial Arterial Line Versus Standard Care in General Surgical Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 25, 2011
Registry last updated
Feb 5, 2016

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.