Postoperative ComplicationsTAPIRNCT02834377
Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery
A study testing Treatment algorithm targeting individual cardiac output in people with Postoperative Complications, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the effectiveness of using the personal preoperatively assessed cardiac output in high-risk patients to guide perioperative administration of fluids and vasoactive drugs on predefined postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Treatment algorithm targeting individual cardiac output
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteGermany
- Study dates
- 19 May 2016to 1 Oct 2017
- Phase
- Interventional
- 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
Who may be able to join
- Patients ≥ 18 years undergoing a major abdominal procedure (including general, urological, gynaecological, and vascular) with an expected duration of surgery ≥ 90 min or presumed blood loss exceeding 1,000 mL (e.g., intrabdominal vascular surgery) and ≥ 1 of the following high-risk criteria:
- acute or chronic renal impairment (serum creatinine ≥ 1.3 mg/dL)
- predefined risk factors for cardiac or respiratory complications
- Immunodeficiency due to a therapy (e.g., immunosuppressants, chemotherapy, radiation, long-term or high-dose steroids)
- Immunodeficiency due to specific diseases (e.g., leukaemia, lymphoma, AIDS)
- severe liver impairment (biopsy proven liver cirrhosis plus 1 of the following: portal hypertension or history of upper gastrointestinal bleeding due to portal hypertension or previous episodes of hepatic insufficiency/hepatic encephalopathy/hepatic coma
- Age ≥ 80 years
Who cannot join
- Age <18 years
- Pregnancy
- surgery for palliative treatment
- emergency procedure
- refusal of consent
- participation in another randomized controlled trial
- failure to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
About this study
Official title: Individualized Goal-directed Hemodynamic Therapy Targeting Preoperatively Assessed Personal Cardiac Output Values in Patients Undergoing High-risk Surgical Procedures: a Prospective and Randomized Clinical Trial
The purpose of this study is to evaluate the effectiveness of using the personal preoperatively assessed cardiac output in high-risk patients to guide perioperative administration of fluids and vasoactive drugs on predefined postoperative complications.
- Conditions
- Postoperative Complications
- Being tested
- Treatment algorithm targeting individual cardiac output
- Keywords
- Cardiac Output, Hemodynamics, Perioperative Care
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment algorithm targeting individual cardiac outputOther
| Study group | Role | What they receive |
|---|---|---|
| Treatment algorithm | Experimental | Patients allocated to the study group will be connected to a cardiac output monitor. An initial haemodynamic assessment will be performed at the beginning of surgery and at regular time intervals (every 15 minutes) during surgery. The personal cardiac output value is targeted. Receives: Other: Treatment algorithm targeting individual cardiac output |
| Standard of Care | No intervention | Patients allocated to the control group will receive the standard care of the hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of study participants with at least one complication of a composite of 30-day postinterventional complications
composite of 30-day postinterventional complications defined according to the ESA-ESICM guidelines for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine (acute kidney injury stage 1 or higher [KIDGO]; ARDS; anastomotic breakdown [moderate and severe]; arrhythmia [severe]; cardiac arrest; cardiogenic pulmonary oedema [severe]; deep vein thrombosis [moderate and severe]; delirium; GI bleeding [severe]; Infection, source uncertain [severe]; bloodstream infection [severe]; myocardial infarction [severe]; pneumonia [severe]; paralytic ileus [severe]; postoperative haemorrhage [severe]; pulmonary embolism [severe]; stroke [severe]; superficial, deep, organ/space surgical site infection [severe]; urinary tract infection [severe]; death)
Measured: up tp 90 days after study enrollment
Secondary outcomes (9)
7-day-mortality
Measured: up to 7 days after study enrollment
30-day-mortality
Measured: up to 30 days after study enrollment
90-day-mortality
Measured: up to 90 days after study enrollment
ICU length of stay
Measured: up to 90 days after study enrollment
hospital length of stay
Measured: up to 90 days after study enrollment
postoperative morbidity survey on days 3, 7, 14, 30
Measured: up to 90 days after study enrollment
postoperative cognitive dysfunction
from day 3 after surgical intervention
Measured: up to 90 days after study enrollment
Biomarkers of the vascular function as prognostic parameters for immunological complications (syndecan 1, sphingosine 1-phosphate, asymmetric dimethylarginine [ADMA], symmetric dimethylarginine [SDMA], arginine, homoarginine
Measured: up to 90 days after study enrollment
perioperative changes of primary metabolites [e. g. citric acid cycle, glycolysis, amino acids metabolism], lipid and phospholipid mediators
Measured: up to 90 days after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study start19 May 2016
- Primary completion30 Jun 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernd Saugel, MD, Study chair, Universitätsklinikum Hamburg-EppendorfJulia Wagner, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834377
- Sponsor's protocol ID
- TAPIR-1.0
- Acronym
- TAPIR
- Status last verified
- Jan 2019
- First submitted
- 1 Jun 2016
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Krieg N, Baumbach P, Ceanga IA, Standke A, Graler MH, Claus RA, Nicklas JY, Winkler MS, Saugel B, Coldewey SM. Prognostic value of perioperative changes in serum primary metabolites in patients after major surgery under general anesthesia: an exploratory secondary analysis of the TAPIR trial. Can J Anaesth. 2025 Jun;72(6):954-965. doi: 10.1007/s12630-025-02984-6. Epub 2025 Jun 30.
PubMed 40586833Nicklas JY, Diener O, Leistenschneider M, Sellhorn C, Schon G, Winkler M, Daum G, Schwedhelm E, Schroder J, Fisch M, Schmalfeldt B, Izbicki JR, Bauer M, Coldewey SM, Reuter DA, Saugel B. Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial. Br J Anaesth. 2020 Aug;125(2):122-132. doi: 10.1016/j.bja.2020.04.094.
PubMed 32711724
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Goal-directed Hemodynamic Therapy Targeting Preoperatively Assessed Personal Cardiac Output Values in Patients Undergoing High-risk Surgical Procedures: a Prospective and Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02834377
- Acronym / sponsor ID
- TAPIR / TAPIR-1.0
- Conditions
- Postoperative Complications
- Keywords
- Cardiac Output, Hemodynamics, Perioperative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 19 May 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 15 Jul 2016 (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.
The purpose of this study is to evaluate the effectiveness of using the personal preoperatively assessed cardiac output in high-risk patients to guide perioperative administration of fluids and vasoactive drugs on predefined postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment algorithm | Experimental | Other: Treatment algorithm targeting individual cardiac outputPatients allocated to the study group will be connected to a cardiac output monitor. An initial haemodynamic assessment will be performed at the beginning of surgery and at regular time intervals (every 15 minutes) during surgery. The personal cardiac output value is targeted. |
| Standard of Care | No intervention | –Patients allocated to the control group will receive the standard care of the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients ≥ 18 years undergoing a major abdominal procedure (including general, urological, gynaecological, and vascular) with an expected duration of surgery ≥ 90 min or presumed blood loss exceeding 1,000 mL (e.g., intrabdominal vascular surgery) and ≥ 1 of the following high-risk criteria:
- acute or chronic renal impairment (serum creatinine ≥ 1.3 mg/dL)
- predefined risk factors for cardiac or respiratory complications
- Immunodeficiency due to a therapy (e.g., immunosuppressants, chemotherapy, radiation, long-term or high-dose steroids)
- Immunodeficiency due to specific diseases (e.g., leukaemia, lymphoma, AIDS)
Key exclusion criteria (7 listed)
- Age <18 years
- Pregnancy
- surgery for palliative treatment
- emergency procedure
- refusal of 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 |
|---|---|---|
| Treatment algorithm targeting individual cardiac output | Other | Treatment algorithm |
Primary outcome
Number of study participants with at least one complication of a composite of 30-day postinterventional complications
Time frame: up tp 90 days after study enrollment
composite of 30-day postinterventional complications defined according to the ESA-ESICM guidelines for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine (acute kidney injury stage 1 or higher [KIDGO]; ARDS; anastomotic breakdown [moderate and severe]; arrhythmia [severe]; cardiac arrest; cardiogenic pulmonary oedema [severe]; deep vein thrombosis [moderate and severe]; delirium; GI bleeding [severe]; Infection, source uncertain [severe]; bloodstream infection [severe]; myocardial infarction [severe]; pneumonia [severe]; paralytic ileus [severe]; postoperative haemorrhage [severe]; pulmonary embolism [severe]; stroke [severe]; superficial, deep, organ/space surgical site infection [severe]; urinary tract infection [severe]; death)
9 secondary outcomes
7-day-mortality
Time frame: up to 7 days after study enrollment
30-day-mortality
Time frame: up to 30 days after study enrollment
90-day-mortality
Time frame: up to 90 days after study enrollment
ICU length of stay
Time frame: up to 90 days after study enrollment
hospital length of stay
Time frame: up to 90 days after study enrollment
postoperative morbidity survey on days 3, 7, 14, 30
Time frame: up to 90 days after study enrollment
postoperative cognitive dysfunction
Time frame: up to 90 days after study enrollment
Biomarkers of the vascular function as prognostic parameters for immunological complications (syndecan 1, sphingosine 1-phosphate, asymmetric dimethylarginine [ADMA], symmetric dimethylarginine [SDMA], arginine, homoarginine
Time frame: up to 90 days after study enrollment
perioperative changes of primary metabolites [e. g. citric acid cycle, glycolysis, amino acids metabolism], lipid and phospholipid mediators
Time frame: up to 90 days after study enrollment
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 29 Jan 2019.
- Derived from this study: PubMed 40586833Krieg N, Baumbach P, Ceanga IA, Standke A, Graler MH, Claus RA, Nicklas JY, Winkler MS, Saugel B, Coldewey SM. Prognostic value of perioperative changes in serum primary metabolites in patients after major surgery under general anesthesia: an exploratory secondary analysis of the TAPIR trial. Can J Anaesth. 2025 Jun;72(6):954-965. doi: 10.1007/s12630-025-02984-6. Epub 2025 Jun 30.
- Derived from this study: PubMed 32711724Nicklas JY, Diener O, Leistenschneider M, Sellhorn C, Schon G, Winkler M, Daum G, Schwedhelm E, Schroder J, Fisch M, Schmalfeldt B, Izbicki JR, Bauer M, Coldewey SM, Reuter DA, Saugel B. Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial. Br J Anaesth. 2020 Aug;125(2):122-132. doi: 10.1016/j.bja.2020.04.094.
- Individual participant dataSharing planned: No
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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.
Bernd Saugel, MD study chair
Universitätsklinikum Hamburg-Eppendorf
Julia Wagner, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment algorithm targeting individual cardiac output in people with Postoperative Complications, run by Universitätsklinikum Hamburg-Eppendorf 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 7 inclusion and 7 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 29 Jan 2019. 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?
Number of study participants with at least one complication of a composite of 30-day postinterventional complications (time frame: up tp 90 days after study enrollment). 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 NCT02834377, which also lists 2 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 29 Jan 2019.