Implementation of a GDT Algorithm for Major Surgery Patients | NCT02509910

Studies
Implementation of a GDT Algorithm for Major Surgery Patients

NCT02509910

Sponsor

Philipps University Marburg

Status

Completed

Last Update Posted

Jul 28, 2015Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Colectomy
Pancreatectomy
Fluid Therapy

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jul 22, 2015

First Submission Date that Met QC Criteria

Jul 25, 2015

First Posted Date

Jul 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2015

Last Update Posted Date

Jul 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Length of stay in hospital		90 days

Secondary Outcomes

Measure	Description	Time Frame
intraoperative crystalloid volume		1 day
intraoperative colloid volume		1 day
Length of stay at ICU

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pancreatic surgery
colorectal surgery

Exclusion Criteria:

admission for revisional surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing major abdominal surgery (Colorectal and pancreatic surgery)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Kratz, MD	Phillips University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Marburg, Department of Anesthesia		Marburg		D-35033	Germany