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Risk Stratification and Goal-directed Volume Therapy

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ClinicalTrials.gov Identifier: NCT01456702
Recruitment Status : Unknown
Verified December 2013 by Michael Sander, Charite University, Berlin, Germany.
Recruitment status was:  Not yet recruiting
First Posted : October 21, 2011
Last Update Posted : December 31, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Fluid Volume Disorder Procedure: risk stratification group

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
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
Study Start Date : October 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. intra- and postoperative volume [ Time Frame: surgical time + treatment time until discharched to the ward or a maximum of 10 hours ]

Secondary Outcome Measures :
  1. treatment time in PACU, ICU, anesthetic recovery room [ Time Frame: admission on PACU, ICU and anesthetic recovery room until a maximum of 10 hours ]
  2. 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 ]
  3. need of blood tranfusions [ Time Frame: intra- and postoperative treatment time with a maximum of 10 hours postoperative ]
  4. incidence of vasopressors [ Time Frame: intra- and postoperative treatment time until a maximum of 10h postoperative ]

Eligibility Criteria

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

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
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

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

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
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 Posted: October 21, 2011    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013

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