Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery (TAPIR)

January 25, 2019 updated by: Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age <18 years
  • Pregnancy
  • surgery for palliative treatment
  • emergency procedure
  • refusal of consent
  • participation in another randomized controlled trial
  • failure to meet inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment algorithm
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.
Other: Treatment algorithm targeting individual cardiac output
No Intervention: Standard of Care
Patients allocated to the control group will receive the standard care of the hospital.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
up tp 90 days after study enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
7-day-mortality
Time Frame: up to 7 days after study enrollment
up to 7 days after study enrollment
30-day-mortality
Time Frame: up to 30 days after study enrollment
up to 30 days after study enrollment
90-day-mortality
Time Frame: up to 90 days after study enrollment
up to 90 days after study enrollment
ICU length of stay
Time Frame: up to 90 days after study enrollment
up to 90 days after study enrollment
hospital length of stay
Time Frame: up to 90 days after study enrollment
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
up to 90 days after study enrollment
postoperative cognitive dysfunction
Time Frame: up to 90 days after study enrollment
from day 3 after surgical intervention
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
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
up to 90 days after study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bernd Saugel, MD, Universitätsklinikum Hamburg-Eppendorf
  • Principal Investigator: Julia Wagner, MD, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAPIR-1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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