Intraoperative Volume Management and QT Interval

• Conditions: Blood Loss, Surgical
• Interventions: Procedure: intra-operative blood loss

• Registration Number: NCT02441751
• Lead Sponsor: Technische Universität Dresden

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.

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-08
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-12
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
bleeding	intra-operative blood loss	intraoperative blood loss \> 500 ml

Primary Outcome Measures

Name	Time	Method
change in QT-time	during operation

Secondary Outcome Measures

Name	Time	Method
survival	1 year	association to intraoperative repolarisation-disturbance / QT-prolongation
postoperative incidents/disturbance rhythm of the heart	2 days	association to intraoperative repolarisation-disturbance / QT-prolongation

Trial Locations

Locations (1)

Dept. of Anesthesia and Intensive Care, University Hospital, Technische Universität Dresden; 🇩🇪 Dresden, Germany