Indication for Intraoperative Volume Therapy (INDIZ IV I)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor Kai Zacharowski, M.D., Ph.D., FRCA, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01454258
First received: October 14, 2011
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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.


Condition
Patients Undergoing Any Kind of Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Indication for Intraoperative Volume Therapy

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Number of different substitution solutions administered [ Time Frame: 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Indication for substitution of the specific solution [ Time Frame: 24h ] [ Designated as safety issue: No ]

Enrollment: 10100
Study Start Date: October 2011
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • patients undergoing surgery receiving at least one bag of cristalloid or colloid solution

Exclusion Criteria:

  • decline of participation
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01454258

Locations
Germany
Goethe University Hospital
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Kai Zacharowski, MD, PhD Johann Wolfgang Goethe University Hospitals
  More Information

No publications provided

Responsible Party: Professor Kai Zacharowski, M.D., Ph.D., FRCA, Director, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01454258     History of Changes
Other Study ID Numbers: INDIZ IV I
Study First Received: October 14, 2011
Last Updated: March 19, 2013
Health Authority: Germany: Institutional Review Board

ClinicalTrials.gov processed this record on September 30, 2014