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Risk Stratification and Goal-directed Volume Therapy

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Michael Sander, Charite University, Berlin, Germany.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01456702
First Posted: October 21, 2011
Last Update Posted: December 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Sander, Charite University, Berlin, Germany
  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
Intervention Model: Parallel Assignment
Masking: None (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 Michael Sander, 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 ]

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 ]
  • 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 ]
  • need of blood tranfusions [ Time Frame: intra- and postoperative treatment time with a maximum of 10 hours postoperative ]
  • incidence of vasopressors [ Time Frame: intra- and postoperative treatment time until a maximum of 10h postoperative ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Michael Sander, Vice Chair, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01456702     History of Changes
Other Study ID Numbers: VoMo
First Submitted: September 29, 2011
First Posted: October 21, 2011
Last Update Posted: December 31, 2013
Last Verified: December 2013

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