Implementation of a GDT Algorithm for Major Surgery Patients

Fluid Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509910
• Other study ID #: UKGMGDT
• 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

• Colectomy
• Fluid Therapy
• Pancreatectomy

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