- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01454258
Indication for Intraoperative Volume Therapy (INDIZ_IV_I)
August 15, 2017 updated by: Professor Kai Zacharowski, M.D., Ph.D., FRCA, Johann Wolfgang Goethe University Hospital
This study evaluates which substitution solutions are used in daily clincal practice in various teaching hospitals in a specific district (Frankfurt/Rhine-Main Metropolitan Region).
Furthermore the indication for usage of these solutions is investigated.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
10100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hessen
-
Frankfurt am Main, Hessen, Germany, 60590
- Goethe University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients of participating hospitals that will undergo surgery and receive intravenous fluid or volume treatment(cristalloid or colloid) will be included.
Participating hospitals are the university teaching hospitals of the Goethe University Hospital
Description
Inclusion Criteria:
- patients undergoing surgery receiving at least one bag of cristalloid or colloid solution
Exclusion Criteria:
- decline of participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Different Substitution Solutions Administered
Time Frame: 24h
|
24h
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kai Zacharowski, MD, PhD, Johann Wolfgang Goethe University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
October 14, 2011
First Submitted That Met QC Criteria
October 14, 2011
First Posted (Estimate)
October 18, 2011
Study Record Updates
Last Update Posted (Actual)
September 14, 2017
Last Update Submitted That Met QC Criteria
August 15, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- INDIZ IV I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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