ClinicalTrials.gov
ClinicalTrials.gov Menu

Risk Stratification and Goal-directed Volume Therapy

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.
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
Sponsor:
Information provided by (Responsible Party):
Michael Sander, Charite University, Berlin, Germany

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 Phase
Fluid Volume Disorder Procedure: risk stratification group Not Applicable

  Show Detailed Description

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

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



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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

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:
SVV
hemodynamic monitoring
goal-directed volume therapie