Intraoperative Volume Management and QT Interval

Blood Loss, Surgical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02441751
• Other study ID #: EK110032015
• Status: Recruiting
• Start date: May 2015
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Technische Universität Dresden
• Contact: Torsten Richter, M.D.
• Phone: 004935145818034
• Email: torsten.richter[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists physical status classification 2 - 3

• patients after consent

Exclusion Criteria:

• Children,

• pregnant women,

• patients not able to consent

Related Conditions & MeSH terms

• Blood Loss, Surgical

Intervention

Procedure:
• intra-operative blood loss
surgery in the urology and orthopedics

Locations

Country	Name	City	State
Germany	Dept. of Anesthesia and Intensive Care, University Hospital, Technische Universität Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in QT-time		during operation
Secondary	postoperative incidents/disturbance rhythm of the heart	association to intraoperative repolarisation-disturbance / QT-prolongation	2 days
Secondary	survival	association to intraoperative repolarisation-disturbance / QT-prolongation	1 year