Intraoperative Volume Management and QT Interval

March 30, 2022 updated by: Technische Universität Dresden

Intraoperative Repolarisation - Etiology and Relevance for the Decision Making by Anesthesiologists in the Management of Volume Substitution and Transfusion

QT interval changes is measured during all phases of the operation. The protocol is focusing at intraoperative bleeding events and is also observing QT interval changes during anesthetic and operative procedures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prolongation of the QT interval is associated with functional torsade de points, re-entry, and sudden death (see reference). Variations of QT-interval caused by changes in the volume status of the patient during an operation remained unclear. QT interval changes will be monitored during the surgery with the focus of the influence of sudden blood loss, volume substitution by crystalloids, blood and blood products. The effect of surgical procedures on the QT-interval (e.g. clamping of kidney artery) will be observed as well as the association of intra-operative QT-interval alterations with postoperative complications.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Recruiting
        • Dept. of Anesthesia and Intensive Care, University Hospital, Technische Universität Dresden
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients for major surgery in urology and orthopedics

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status classification 2 - 3
  • patients after consent

Exclusion Criteria:

  • Children,
  • pregnant women,
  • patients not able to consent

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
bleeding
intraoperative blood loss > 500 ml
Procedure: intra-operative blood loss
surgery in the urology and orthopedics
no bleeding
intraoperative blood loss < 500 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in QT-time
Time Frame: during operation
during operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative incidents/disturbance rhythm of the heart
Time Frame: 2 days
association to intraoperative repolarisation-disturbance / QT-prolongation
2 days
survival
Time Frame: 1 year
association to intraoperative repolarisation-disturbance / QT-prolongation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Study Director: Torsten Richter, M.D., University Hospital Dresden, TU Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2015

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 8, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK110032015

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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