Perioperative/Postoperative ComplicationsNCT03765372
Evaluation of BIomarkers for POstoperative Complications in Non-cardiac Surgery Patients
An observational study of Perioperative/Postoperative Complications and Outcome, run by Technical University of Munich at 1 site in Germany.
Trial summary
Aim of this study is to evaluate whether the periopertive course is able to predict postoperative complications. Several approaches will be choosed to optimize perioperative risk stratification predicting postoperative complications in patients undergoing elective non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative/Postoperative Complications, Outcome
- How many people
- 1,598 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jun 2017to 18 Dec 2021
- How long will I take part?
- 4 Weeks
- 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: High risk patients (ASA Status 3 or 4) and / or patients undergoing elective non-cardiac high risk surgery at the Klinikum rechts der Isar, Munich.
Who may be able to join
- written informed consense
- Age > 18 years
- ASA Score 3 or 4
- elective non-cardiac high risk surgery
Who cannot join
- emergency surgery
- need for dialysis
- liver cirrhosis child C
- intolerance of albumin
- participation in other AMG (medicines law) study
- pregnancy or breastfeeding
Show all 9Show fewer
- patients with attendants concerning medical matters
- ASA V patients
- patients with BMI > 35 kg/m2
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum Rechts der Isar, Technische Universität München
München, Bavaria, 81675
About this study
Official title: Evaluation of hsTnT for Perioperative Risk Stratification Among Patients Undergoing Elective Non-cardiac Surgery
Aim of this study is to evaluate whether the periopertive course is able to predict postoperative complications. Several approaches will be choosed to optimize perioperative risk stratification predicting postoperative complications in patients undergoing elective non-cardiac surgery.
Read the detailed description
The aim of this secondary analysis of the SUPERADD study is to use the perioperative data from the prospective SUPERADD study ("SUbstitution of PERioperative Albumin Deficiency Disorders") (Eudra-CT 2016-001313-24; Clinical Trials NCT03167645; DOI: 10.1097) to identify risk factors for the occurrence of postoperative complications, based on the Clavien-Dindo classification in the nine domains of the Postoperative Morbidity Survey.
Multivariate Analyses, Decision trees, time series analysis and Machine Learning methods will be applied to distinguish risk factors for postoperative complikations and mortality in a high-risk group (see publication of the statistical analysis plan and its enhancement).
Patients participating in the SUPERADD study (NCT03167656) and who had at least two perioperative high sensitive Troponin T (hsTnT) values in order to detect myocardial injury were included in this secondary analysis as hsTnT is associated with major adverse cardiovascular events (MACE), myocardial injury after noncardiac surgery and mortality.
The secondary analysis uses data obtained at the pre-anaesthesia visit like ASA, preoperative comorbidities measured by the POSPOM, CCI, intraoperative parameters like vitals, medication, estimated blood loss and postoperative data obtained from PACU records and discharge letter. Primary Endpoint are postoperative complications assessed with the Cavien-Dindo classification > 2.
- Conditions
- Perioperative/Postoperative Complications, Outcome
- Keywords
- perioperative outcome, clavien-dindo classification, hsTnT, MINS
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative complications determined with the calvien-dindo classification
Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, haematological and pain. Each domain is graded between grade I and V (death of a patient).
Measured: date of surgery until hospital discharge (approx. 30 days)
Secondary outcomes (4)
hospital mortality
Rate of Mortality among study patients
Measured: date of surgery until hospital discharge (approx. 30 days)
Acute Kidney Injury
Acute Kidney Injury according to KDIGO
Measured: postoperative day 2
Myocardial Injury
perioperative hsTnT course, including preoperative hsTnT measurements
Measured: postoperative day 2
6 months mortalitiy
Rate of Mortality among study patients
Measured: date of surgery until 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start19 Jun 2017
- Primary completion1 Nov 2019
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,598 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bettina Jungwirth, Prof., Study director, Department of Anesthesia, Klinikum rechts der Isar, TU Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765372
- Sponsor's protocol ID
- BiPoC
- Status last verified
- Dec 2021
- First submitted
- 28 Nov 2018
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anetsberger A, Blobner M, Haller B, Schmid S, Umgelter K, Hager T, Langgartner C, Kochs EF, Laugwitz KL, Jungwirth B, Bernlochner I. Immature platelets as a novel biomarker for adverse cardiovascular events in patients after non-cardiac surgery. Thromb Haemost. 2017 Oct 5;117(10):1887-1895. doi: 10.1160/TH16-10-0804. Epub 2017 Aug 10.
PubMed 28796275Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.
PubMed 28444280Ma J, Xin Q, Wang X, Gao M, Wang Y, Liu J. Prediction of perioperative cardiac events through preoperative NT-pro-BNP and cTnI after emergent non-cardiac surgery in elderly patients. PLoS One. 2015 Mar 23;10(3):e0121306. doi: 10.1371/journal.pone.0121306. eCollection 2015.
PubMed 25799524Vetrugno L, Costa MG, Pompei L, Chiarandini P, Drigo D, Bassi F, Gonano N, Muzzi R, Della Rocca G. Prognostic power of pre- and postoperative B-type natriuretic peptide levels in patients undergoing abdominal aortic surgery. J Cardiothorac Vasc Anesth. 2012 Aug;26(4):637-42. doi: 10.1053/j.jvca.2012.01.018. Epub 2012 Mar 2.
PubMed 22387082
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of hsTnT for Perioperative Risk Stratification Among Patients Undergoing Elective Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT03765372
- Acronym / sponsor ID
- BiPoC
- Conditions
- Perioperative/Postoperative Complications, Outcome
- Keywords
- perioperative outcome, clavien-dindo classification, hsTnT, MINS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,598 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 5 Dec 2018 (actual)
- 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.
Aim of this study is to evaluate whether the periopertive course is able to predict postoperative complications. Several approaches will be choosed to optimize perioperative risk stratification predicting postoperative complications in patients undergoing elective non-cardiac surgery.
Detailed description
The aim of this secondary analysis of the SUPERADD study is to use the perioperative data from the prospective SUPERADD study ("SUbstitution of PERioperative Albumin Deficiency Disorders") (Eudra-CT 2016-001313-24; Clinical Trials NCT03167645; DOI: 10.1097) to identify risk factors for the occurrence of postoperative complications, based on the Clavien-Dindo classification in the nine domains of the Postoperative Morbidity Survey.
Multivariate Analyses, Decision trees, time series analysis and Machine Learning methods will be applied to distinguish risk factors for postoperative complikations and mortality in a high-risk group (see publication of the statistical analysis plan and its enhancement).
Patients participating in the SUPERADD study (NCT03167656) and who had at least two perioperative high sensitive Troponin T (hsTnT) values in order to detect myocardial injury were included in this secondary analysis as hsTnT is associated with major adverse cardiovascular events (MACE), myocardial injury after noncardiac surgery and mortality.
The secondary analysis uses data obtained at the pre-anaesthesia visit like ASA, preoperative comorbidities measured by the POSPOM, CCI, intraoperative parameters like vitals, medication, estimated blood loss and postoperative data obtained from PACU records and discharge letter. Primary Endpoint are postoperative complications assessed with the Cavien-Dindo classification > 2.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High risk patients (ASA Status 3 or 4) and / or patients undergoing elective non-cardiac high risk surgery at the Klinikum rechts der Isar, Munich.
Key inclusion criteria (4 listed)
- written informed consense
- Age > 18 years
- ASA Score 3 or 4
- elective non-cardiac high risk surgery
Key exclusion criteria (9 listed)
- emergency surgery
- need for dialysis
- liver cirrhosis child C
- intolerance of albumin
- participation in other AMG (medicines law) study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative complications determined with the calvien-dindo classification
Time frame: date of surgery until hospital discharge (approx. 30 days)
Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, haematological and pain. Each domain is graded between grade I and V (death of a patient).
4 secondary outcomes
hospital mortality
Time frame: date of surgery until hospital discharge (approx. 30 days)
Acute Kidney Injury
Time frame: postoperative day 2
Myocardial Injury
Time frame: postoperative day 2
6 months mortalitiy
Time frame: date of surgery until 6 months after
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Results publication: PubMed 28796275Anetsberger A, Blobner M, Haller B, Schmid S, Umgelter K, Hager T, Langgartner C, Kochs EF, Laugwitz KL, Jungwirth B, Bernlochner I. Immature platelets as a novel biomarker for adverse cardiovascular events in patients after non-cardiac surgery. Thromb Haemost. 2017 Oct 5;117(10):1887-1895. doi: 10.1160/TH16-10-0804. Epub 2017 Aug 10.
- Results publication: PubMed 28444280Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.
- Results publication: PubMed 25799524Ma J, Xin Q, Wang X, Gao M, Wang Y, Liu J. Prediction of perioperative cardiac events through preoperative NT-pro-BNP and cTnI after emergent non-cardiac surgery in elderly patients. PLoS One. 2015 Mar 23;10(3):e0121306. doi: 10.1371/journal.pone.0121306. eCollection 2015.
- Results publication: PubMed 22387082Vetrugno L, Costa MG, Pompei L, Chiarandini P, Drigo D, Bassi F, Gonano N, Muzzi R, Della Rocca G. Prognostic power of pre- and postoperative B-type natriuretic peptide levels in patients undergoing abdominal aortic surgery. J Cardiothorac Vasc Anesth. 2012 Aug;26(4):637-42. doi: 10.1053/j.jvca.2012.01.018. Epub 2012 Mar 2.
Related trials for Perioperative/Postoperative Complications
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Active, not recruiting
Prehabilitation in Pancreatic Surgery
Pancreatic Cancer, Periampullary Cancer
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
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.
Bettina Jungwirth, Prof. study director
Department of Anesthesia, Klinikum rechts der Isar, TU Munich
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 Perioperative/Postoperative Complications and Outcome, run by Technical University of Munich 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 6 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative complications determined with the calvien-dindo classification (time frame: date of surgery until hospital discharge (approx. 30 days)). 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 NCT03765372, which also lists 4 linked publications.
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 6 Mar 2024.