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

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT01384097
• Collaborator: (none)
• Enrollment: 774
• Location: 1
• Duration (Months): 45
• Patients Per Site Per Month: 17.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fracture of Surgical Neck of Humerus; Colonic Tumor; Stage IIIB Ovarian Carcinoma; Neoplasm of Head of Pancreas

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 774 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: An Algorithm for Intra-operative Goal-directed Haemodynamic Management in Non-cardiac Surgery - a Feasibility Study
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Conventional care patients treated by conventional haemodynamic care intraoperatively
Haemodynamic algorithm patients treated within a goal-directed haemodynamic algorithm intraoperatively

Outcome Measures

Primary Outcome Measures

1. hospital length of stay [a period of 60 days]

   The perioperative hospital length of stay is assessed.

Secondary Outcome Measures

1. need for ventilator therapy [a period of 60 days]

   The perioperative need for ventilator therapy is assessed.

2. monetary reimbursement for prolonged hospital stay [a period of 60 days]

   The monetary reimbursement for prolonged hospital stay is assessed to evaluate the impact on financial consequences.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité - University Medicine Berlin	Berlin		Germany	13353

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

• Principal Investigator: Claudia Spies, MD Prof., Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The homepage of the Department of Anesthesiology and Intensive Care Medicine at the Charité - University Medicine Berlin

Publications

None provided.

• Responsible Party: Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT01384097
• Other Study ID Numbers: ERAS_feasibility
• First Posted: Jun 28, 2011
• Last Update Posted: Sep 8, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Charite University, Berlin, Germany: haemodynamic; goal-directed therapy; surgery; anaesthesia
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Colonic Neoplasms

Study Results

No Results Posted as of Sep 8, 2011