An Algorithm for Intra-operative Goal-directed Haemodynam... | NCT01384097

Studies
An Algorithm for Intra-operative Goal-directed Haemodynamic Management in Non-cardiac Surgery

NCT01384097

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Sep 8, 2011Estimated

Enrollment

774Actual

Phase

Not provided

Conditions

Fracture of Surgical Neck of Humerus
Colonic Tumor
Stage IIIB Ovarian Carcinoma
Neoplasm of Head of Pancreas

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

Sep 2011

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

Sep 2007

Primary Completion Date

Feb 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jun 27, 2011

First Submission Date that Met QC Criteria

Jun 27, 2011

First Posted Date

Jun 28, 2011Estimated

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

Sep 7, 2011

Last Update Posted Date

Sep 8, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

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

A systematic literature search a goal-directed haemodynamic algorithm was created. The hypothesis of this study was that the goal-directed haemodynamic algorithm is feasible and can improve clinical outcome.

Detailed Description

After a systematic literature search a goal-directed haemodynamic algorithm was created. The algorithm was adapted to international standards and consensus was reached through a modified Delphi method at international meetings. The feasibility of using the algorithm for intraoperative haemodynamic management was tested and the resultant clinical data analyzed retrospectively for several types of surgery with the hypothesis that the goal-directed haemodynamic algorithm is feasible in the clinical setting and can improve clinical outcome.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

774Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional care		patients treated by conventional haemodynamic care intraoperatively
Haemodynamic algorithm		patients treated within a goal-directed haemodynamic algorithm intraoperatively

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hospital length of stay	The perioperative hospital length of stay is assessed.	a period of 60 days

Secondary Outcomes

Measure	Description	Time Frame
need for ventilator therapy	The perioperative need for ventilator therapy is assessed.	a period of 60 days
monetary reimbursement for prolonged hospital stay	The monetary reimbursement for prolonged hospital stay is assessed to evaluate the impact on financial consequences.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing a surgical repair of hip fractures, open right hemicolectomy and extended hemicolectomy, radical tumor debulking in primary ovarian cancer or a pylorus-preserving pancreatic head resection at the Charité - University Medicine Berlin, Campus Virchow Clinic
18 years and older

Exclusion Criteria:

emergency procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing a surgical repair of hip fractures, open right hemicolectomy and extended hemicolectomy, radical tumor debulking in primary ovarian cancer or a pylorus-preserving pancreatic head resection.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudia Spies, MD Prof.	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité - University Medicine Berlin		Berlin	State of Berlin	13353	Germany

References Module

Citations

Not provided

ID	Term
D003110	Colonic Neoplasms
D010051	Ovarian Neoplasms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms