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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02509910
Other study ID # UKGMGDT
Secondary ID
Status Completed
Phase N/A
First received July 22, 2015
Last updated July 25, 2015
Start date July 2013
Est. completion date July 2015

Study information

Verified date July 2015
Source Philipps University Marburg Medical Center
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- pancreatic surgery

- colorectal surgery

Exclusion Criteria:

- admission for revisional surgery

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Hospital of Marburg, Department of Anesthesia Marburg

Sponsors (1)

Lead Sponsor Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of stay in hospital 90 days No
Secondary intraoperative crystalloid volume 1 day No
Secondary intraoperative colloid volume 1 day No
Secondary Length of stay at ICU 90 days No
Secondary Total amount of complications per patient 90 days No
Secondary Insufficiance of bowel anastomosis 90 days No
Secondary Pneumonia 90 days No
Secondary ACS 90 days No
Secondary acute renal failure 90 days No
Secondary Sepsis 90 days No
Secondary Intraabd. Infection 90 days No
Secondary wound infection 90 days No
Secondary UTI 90 days No
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