Risk Stratification and Goal-directed Volume Therapy

This study is not yet open for participant recruitment.
Verified December 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Michael Sander, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01456702
First received: September 29, 2011
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

It is difficulte to evaluate risk patients and to find the ideal intraoperative volume management. It seems to be that ill patients benefit of a goal directed volume management. The aim of this study is to implement the guidelines on perioperative cardiovascular evaluation and care for non-cardiac sugery and to improve perioperative a goal-directed protocoll for volume management.


Condition Intervention
Fluid Volume Disorder
Procedure: risk stratification group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Influence of Pre-operative Risk Stratefiction and Intraoperaitve Monitoring on Perioperative Volume Therapy and Postoperative Outcome

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

Primary Outcome Measures:
  • intra- and postoperative volume [ Time Frame: surgical time + treatment time until discharched to the ward or a maximum of 10 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • treatment time in PACU, ICU, anesthetic recovery room [ Time Frame: admission on PACU, ICU and anesthetic recovery room until a maximum of 10 hours ] [ Designated as safety issue: No ]
  • incidence of delirium and PONV [ Time Frame: admission on ICU, PACU, anesthetic recovery room until discharge to the ward or a maximum of 10 hours ] [ Designated as safety issue: No ]
  • need of blood tranfusions [ Time Frame: intra- and postoperative treatment time with a maximum of 10 hours postoperative ] [ Designated as safety issue: No ]
  • incidence of vasopressors [ Time Frame: intra- and postoperative treatment time until a maximum of 10h postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control arm
volume therapy via standard operating procedure
Experimental: intervention arm
goal-directed volume therapy due to svv in dependence of preoperative risk stratefication
Procedure: risk stratification group
goal-directed volume therapy due to svv measurement or volume therapy via standard operated procedures in dependence of cardiac risk factores
Other Name: svv group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • electiv orthopedic surgery with intermediate risk surgery
  • signed informed consent
  • >18 years

Exclusion Criteria:

  • No consent for the study
  • Age < 18 years
  • Emergency surgery
  • Pregnant women
  • Jehovah`s Witnesses
  • Myocardial infarction in the last 4 weeks
  • High-risk cardiac factors
  • GOLD IV
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456702

Contacts
Contact: Michael Sander, MD +49-30-450531 ext 052 michael.sander@charite.de

Locations
Germany
Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin Not yet recruiting
Berlin, Germany, 10117
Contact: Michael Sander, MD    +49-30-450 531 ext 052    michael.sander@charite.de   
Sub-Investigator: Alexandra Lau, MD         
Sub-Investigator: Michael Krämer, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Michael Sander, MD Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
  More Information

No publications provided

Responsible Party: Michael Sander, Vice Chair, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01456702     History of Changes
Other Study ID Numbers: VoMo
Study First Received: September 29, 2011
Last Updated: December 30, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
SVV
hemodynamic monitoring
goal-directed volume therapie

ClinicalTrials.gov processed this record on April 17, 2014