Blood Loss, SurgicalNCT02441751
Intraoperative Volume Management and QT Interval
An observational study of Blood Loss, Surgical, run by Technische Universität Dresden at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- intra-operative blood loss
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients for major surgery in urology and orthopedics
Who may be able to join
- American Society of Anesthesiologists physical status classification 2 - 3
- patients after consent
Who cannot join
- Children,
- pregnant women,
- patients not able to consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Anesthesia and Intensive Care, University Hospital, Technische Universität Dresden
Dresden, 01307
Torsten Richter, M.D., 004935145818034, torsten.richter@uniklinikum-dresden.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Loss, Surgical
- Being tested
- intra-operative blood loss
- Keywords
- Electrocardiography, Hemorrhage, Monitoring, Intraoperative
- Medical subject headings
- Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-operative blood lossProcedure or surgery
surgery in the urology and orthopedics
| Study group | Role | What they receive |
|---|---|---|
| bleeding | intraoperative blood loss > 500 ml Receives: Procedure: intra-operative blood loss | |
| no bleeding | intraoperative blood loss < 500 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in QT-time
Measured: during operation
Secondary outcomes (2)
postoperative incidents/disturbance rhythm of the heart
association to intraoperative repolarisation-disturbance / QT-prolongation
Measured: 2 days
survival
association to intraoperative repolarisation-disturbance / QT-prolongation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2015
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torsten Richter, M.D., Study director, University Hospital Dresden, TU Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02441751
- Sponsor's protocol ID
- EK110032015
- Status last verified
- Mar 2022
- First submitted
- 8 May 2015
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.jacc.2005.08.067.
PubMed 16412861
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Repolarisation - Etiology and Relevance for the Decision Making by Anesthesiologists in the Management of Volume Substitution and Transfusion
- ClinicalTrials.gov ID
- NCT02441751
- Acronym / sponsor ID
- EK110032015
- Conditions
- Blood Loss, Surgical
- Keywords
- Electrocardiography, Hemorrhage, Monitoring, Intraoperative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bleeding | – | Procedure: intra-operative blood lossintraoperative blood loss > 500 ml |
| no bleeding | – | –intraoperative blood loss < 500 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients for major surgery in urology and orthopedics
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status classification 2 - 3
- patients after consent
Key exclusion criteria (3 listed)
- Children,
- pregnant women,
- patients not able to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra-operative blood losssurgery in the urology and orthopedics | Procedure or surgery | bleeding |
Primary outcome
change in QT-time
Time frame: during operation
2 secondary outcomes
postoperative incidents/disturbance rhythm of the heart
Time frame: 2 days
survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 16412861Straus 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. doi: 10.1016/j.jacc.2005.08.067.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torsten Richter, M.D. study director
University Hospital Dresden, TU Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Loss, Surgical, run by Technische Universität Dresden at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Torsten Richter, M.D. (004935145818034, torsten.richter@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in QT-time (time frame: during operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02441751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.