Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery - Clinical Trial for Postoperative Complications | NCT02834377

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Treatment algorithm targeting individual cardiac output

About this trial

This is an interventional treatment trial for Postoperative Complications focused on measuring Cardiac Output, Hemodynamics, Perioperative Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment algorithm

Standard of Care

Arm Description

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.

Patients allocated to the control group will receive the standard care of the hospital.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

7-day-mortality

30-day-mortality

90-day-mortality

ICU length of stay

hospital length of stay

postoperative morbidity survey on days 3, 7, 14, 30

postoperative cognitive dysfunction

from day 3 after surgical intervention

Biomarkers of the vascular function as prognostic parameters for immunological complications (syndecan 1, sphingosine 1-phosphate, asymmetric dimethylarginine [ADMA], symmetric dimethylarginine [SDMA], arginine, homoarginine

perioperative changes of primary metabolites [e. g. citric acid cycle, glycolysis, amino acids metabolism], lipid and phospholipid mediators

Full Information

NCT ID

NCT02834377

First Posted

June 1, 2016

Last Updated

January 25, 2019

Sponsor

Universitätsklinikum Hamburg-Eppendorf

1. Study Identification

Unique Protocol Identification Number

NCT02834377

Brief Title

Personalized Hemodynamic Therapy in Patients Undergoing High-risk Surgery

Acronym

TAPIR

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

May 19, 2016 (Actual)

Primary Completion Date

June 30, 2017 (Actual)

Study Completion Date

October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Complications

Keywords

Cardiac Output, Hemodynamics, Perioperative Care

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

188 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment algorithm

Arm Type

Experimental

Arm Description

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.

Arm Title

Standard of Care

Arm Type

No Intervention

Arm Description

Patients allocated to the control group will receive the standard care of the hospital.

Intervention Type

Other

Intervention Name(s)

Treatment algorithm targeting individual cardiac output

Primary Outcome Measure Information:

Title

Number of study participants with at least one complication of a composite of 30-day postinterventional complications

Description

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)

Time Frame

up tp 90 days after study enrollment

Secondary Outcome Measure Information:

Title

7-day-mortality

Time Frame

up to 7 days after study enrollment

Title

30-day-mortality

Time Frame

up to 30 days after study enrollment

Title

90-day-mortality

Time Frame