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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01384097
First received: June 27, 2011
Last updated: September 7, 2011
Last verified: September 2011
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Algorithm for Intra-operative Goal-directed Haemodynamic Management in Non-cardiac Surgery - a Feasibility Study

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • hospital length of stay [ Time Frame: a period of 60 days ] [ Designated as safety issue: No ]
    The perioperative hospital length of stay is assessed.


Secondary Outcome Measures:
  • need for ventilator therapy [ Time Frame: a period of 60 days ] [ Designated as safety issue: No ]
    The perioperative need for ventilator therapy is assessed.

  • monetary reimbursement for prolonged hospital stay [ Time Frame: a period of 60 days ] [ Designated as safety issue: No ]
    The monetary reimbursement for prolonged hospital stay is assessed to evaluate the impact on financial consequences.


Enrollment: 774
Study Start Date: September 2007
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Conventional care
patients treated by conventional haemodynamic care intraoperatively
Haemodynamic algorithm
patients treated within a goal-directed haemodynamic algorithm intraoperatively

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384097

Locations
Germany
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
  More Information

Additional Information:
No publications 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     History of Changes
Other Study ID Numbers: ERAS_feasibility
Study First Received: June 27, 2011
Last Updated: September 7, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
haemodynamic
goal-directed therapy
surgery
anaesthesia

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Colonic Neoplasms
Head and Neck Neoplasms
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on August 26, 2014