NCT02509910

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

2 years

First QC Date

July 22, 2015

Last Update Submit

July 25, 2015

Conditions

ColectomyPancreatectomyFluid Therapy

Keywords

Major abdominal surgeryGoal directed therapy

Outcome Measures

Primary Outcomes (1)

  • Length of stay in hospital

    90 days

Secondary Outcomes (12)

  • intraoperative crystalloid volume

    1 day

  • intraoperative colloid volume

    1 day

  • Length of stay at ICU

    90 days

  • Total amount of complications per patient

    90 days

  • Insufficiance of bowel anastomosis

    90 days

  • +7 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing major abdominal surgery (Colorectal and pancreatic surgery)

You may qualify if:

  • pancreatic surgery
  • colorectal surgery

You may not qualify if:

  • admission for revisional surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Marburg, Department of Anesthesia

Marburg, D-35033, Germany

Location

Study Officials

  • Thomas Kratz, MD

    Phillips University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 28, 2015

Study Start

July 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 28, 2015

Record last verified: 2015-07

Locations

DE(1)