Risk Stratification and Goal-directed Volume Therapy
Influence of Pre-operative Risk Stratefiction and Intraoperaitve Monitoring on Perioperative Volume Therapy and Postoperative Outcome
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2011
CompletedFirst Posted
Study publicly available on registry
October 21, 2011
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedDecember 31, 2013
December 1, 2013
1.2 years
September 29, 2011
December 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intra- and postoperative volume
surgical time + treatment time until discharched to the ward or a maximum of 10 hours
Secondary Outcomes (4)
treatment time in PACU, ICU, anesthetic recovery room
admission on PACU, ICU and anesthetic recovery room until a maximum of 10 hours
incidence of delirium and PONV
admission on ICU, PACU, anesthetic recovery room until discharge to the ward or a maximum of 10 hours
need of blood tranfusions
intra- and postoperative treatment time with a maximum of 10 hours postoperative
incidence of vasopressors
intra- and postoperative treatment time until a maximum of 10h postoperative
Study Arms (2)
control arm
NO INTERVENTIONvolume therapy via standard operating procedure
intervention arm
EXPERIMENTALgoal-directed volume therapy due to svv in dependence of preoperative risk stratefication
Interventions
goal-directed volume therapy due to svv measurement or volume therapy via standard operated procedures in dependence of cardiac risk factores
Eligibility Criteria
You may qualify if:
- electiv orthopedic surgery with intermediate risk surgery
- signed informed consent
- \>18 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10117, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Sander, MD
Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chair
Study Record Dates
First Submitted
September 29, 2011
First Posted
October 21, 2011
Study Start
October 1, 2014
Primary Completion
December 1, 2015
Study Completion
March 1, 2016
Last Updated
December 31, 2013
Record last verified: 2013-12