Implementation of a GDT Algorithm for Major Surgery Patients

July 25, 2015 updated by: Dr. Thomas Kratz, Philipps University Marburg Medical Center

Implementation and Effects of Pulse-contour-automated SVV/CI Guided Goal Directed Fluid Therapy Algorithm for the Routine Management of Major Abdominal Surgery Patients

This study examines the effect of an algorithm for GDT for patients undergoing major surgery under routine conditions.

Study Overview

Status

Completed

Conditions

Detailed Description

Goal directed fluid management in major abdominal surgery has been shown to reduce perioperative complications. The approach aims to optimize the intravascular fluid volume by use of minimally invasive devices which calculate flow-directed variables such as stroke volume (SV) and stroke volume variation (SVV). The investigators aim to show the feasibility of routinely implementing such hemodynamic monitoring during major abdominal surgery, and to evaluate its effects in terms of perioperative fluid management and postoperative outcomes.

Study Type

Observational

Enrollment (Actual)

300

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
      • Marburg, Germany, D-35033
        • University Hospital of Marburg, Department of Anesthesia

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing major abdominal surgery (Colorectal and pancreatic surgery)

Description

Inclusion Criteria:

  • pancreatic surgery
  • colorectal surgery

Exclusion Criteria:

  • admission for revisional surgery

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

Cohorts and Interventions

Group / Cohort
Standard therapy
intraoperative standard fluid therapy for major abdominal surgery
Goal directed therapy
intraoperative goal directed fluid therapy based on an angorithm lead by SVV/CI for major abdominal surgery patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of stay in hospital
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
intraoperative crystalloid volume
Time Frame: 1 day
1 day
intraoperative colloid volume
Time Frame: 1 day
1 day
Length of stay at ICU
Time Frame: 90 days
90 days
Total amount of complications per patient
Time Frame: 90 days
90 days
Insufficiance of bowel anastomosis
Time Frame: 90 days
90 days
Pneumonia
Time Frame: 90 days
90 days
ACS
Time Frame: 90 days
90 days
acute renal failure
Time Frame: 90 days
90 days
Sepsis
Time Frame: 90 days
90 days
Intraabd. Infection
Time Frame: 90 days
90 days
wound infection
Time Frame: 90 days
90 days
UTI
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

Philipps University Marburg Medical Center

Investigators

  • Principal Investigator: Thomas Kratz, MD, Phillips University

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

July 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

July 25, 2015

First Posted (Estimate)

July 28, 2015

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 25, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UKGMGDT

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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