Intraoperative Volume Management and QT Interval

• Sponsor: Technische Universität Dresden (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02441751
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 104
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Loss, Surgical	Procedure: intra-operative blood loss

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 Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Intraoperative Repolarisation - Etiology and Relevance for the Decision Making by Anesthesiologists in the Management of Volume Substitution and Transfusion
• Study Start Date: May 1, 2015
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. change in QT-time [during operation]

Secondary Outcome Measures

1. postoperative incidents/disturbance rhythm of the heart [2 days]

   association to intraoperative repolarisation-disturbance / QT-prolongation

2. survival [1 year]

   association to intraoperative repolarisation-disturbance / QT-prolongation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• American Society of Anesthesiologists physical status classification 2 - 3

• patients after consent

Exclusion Criteria:

• Children,

• pregnant women,

• patients not able to consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Anesthesia and Intensive Care, University Hospital, Technische Universität Dresden	Dresden		Germany	01307

Sponsors and Collaborators

• Technische Universität Dresden

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Straus SM, Kors JA, De Bruin ML, van der Hooft CS, Hofman A, Heeringa J, Deckers JW, Kingma JH, Sturkenboom MC, Stricker BH, Witteman JC. Prolonged QTc interval and risk of sudden cardiac death in a population of older adults. J Am Coll Cardiol. 2006 Jan 17;47(2):362-7.

• Responsible Party: Technische Universität Dresden
• ClinicalTrials.gov Identifier: NCT02441751
• Other Study ID Numbers: EK110032015
• First Posted: May 12, 2015
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Keywords provided by Technische Universität Dresden: Electrocardiography; Hemorrhage; Monitoring, Intraoperative
• Additional relevant MeSH terms: Blood Loss, Surgical

Study Results

No Results Posted as of Mar 31, 2022