Verification of a New Predictive Delirium Score in Adults With Elective Cardiac Valve or Bypass Surgery With Perioperative Use of a Heart-lung Machine; a Monocentric Pilot Observational Study (MO-FA2-(TB))

March 5, 2026 updated by: University Hospital Tuebingen

Predictors for the Development of Perioperative Delirium in Adult Patients Undergoing Elective Cardiac Surgery

Basics (state of scientific knowledge):

Delirium is an acute disturbance of consciousness and attention that develops over a short period of time and fluctuates in severity. It is accompanied by a deterioration in cognitive performance, such as memory deficits, disorientation, and speech and thinking disorders, which significantly exceed the degree of any pre-existing limitations . Surgery and intensive medical treatment are considered to be two of the triggers.

In cardiac surgery, the incidence is reported to be between 10 and 50%, depending on the patient population. Delirium occurs approximately 3-4 days after surgery and lasts for several days. Relevant factors in the cardiac surgery population include age, duration of aortic clamping time or surgical technique, pre-existing conditions such as the extent of heart failure (EuroScore), diabetes mellitus, mental and cognitive impairments, or carotid stenosis.

Both current studies and current recommendations emphasize prevention and the lack of successful treatment options. Preventive measures are primarily investigated in packages of measures. The study presented here aims to define risk populations and test the sensitivity and specificity of the MO-FA2-(TB) score for the development of delirium.

Objectives of the study:

Verification of the predictive score "MO-FA2-(TB)" for the development of postoperative delirium Recording of delirium and associated influencing factors and endpoints

Categories examined in the score:

Memory using a list of words that must be memorized and repeated after a few minutes Orientation by asking about the year, month, date, day of the week, city, and location Frailty using the ASA score Use of heart-lung machine Incision-suture time

Study duration (for individual subjects):

postoperative intensive care stay up to and including day 10

Study population Patients who have to undergo cardiac surgery with CPB

Inclusion criteria:

Elective cardiac surgery Heart valve surgery, bypass surgery with CPB Length of stay in ICU > 48 hours Age ≥18 years Fluent German language skills

Exclusion criteria:

Age <18 years Lack of capacity to give consent Emergency Readmission to intensive care unit OPCAB surgery, microsurgical procedure

Recruitment: Information provided the day before surgery based on the surgical schedule If consent is given, score is recorded If ICU stay >48 hours, treatment data is recorded, otherwise exclusion Data collection up to and including d10

Treatment data collected:

Preoperative data, including ejection fraction, aids, abuse, scores collected ("4AT test" for rapid assessment of delirium and cognitive impairment, "MO-FA2-(TB)", "geriatric check" for identifying a geriatric patient) Intraoperative data, including duration of surgery, duration of heart-lung machine, acidosis Postoperative data in ICU, including delirium scores (ICDSC, CAM-ICU), days on ventilation, days of treatment, fluid intake, medication related to delirium, organ replacement therapy such as dialysis

Number of cases: Approx. 100 patients

Methodology Monocentric, observation

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The data listed below is collected from the PDMS if the patient has been in the ICU for more than 48 hours.

Master data and pre-existing conditions Age (at admission) Case number Gender Diagnosis Cardiac ejection fraction in % Type of surgery According to surgical protocol Dementia yes/no Hearing aid yes/no Glasses yes/no Abuse: nicotine, alcohol, drugs Premedication with benzodiazepines yes/no

Preoperative data 4AT test Collected yes/no, four factors MO-FA2-(TB) Detailed score Geriatric check Collected yes/no, result Deviation of surgical planning from surgical program Difference in surgical sites Planned duration of surgery Minutes

Intraoperative data pO2 Percentage drop below induction values Acidosis yes/no Number of pH < 7.3; Lactateemia: max lactate concentration nmol/l Maximum in mmol/l Actual surgery duration Minutes Duration of heart-lung machine Minutes Blood loss Number of blood units administered Type of anesthesia TIVA yes/no; conduction anesthesia (spinal, EDC, block)

Data collection in ICU Diagnosis of delirium (date) Recorded daily by ICDSC and CAM-ICU Delirium score >50%/d pos. / not recorded Daily Days/hours of ventilation Total in hours NIV >3x1.5h yes/no Days of treatment in ICU Total for > 2 days of stay in ICU Place of discharge (recorded on day 28) IMC/general ward (+sitting guard)/ext. Hospital/Rehab/Home ventilation/Death Fluid intake 24h Liters daily Organ replacement therapy Dialysis / Plasmapheresis daily Tracheotomy Yes/no / Days with tracheostoma Singer Index Number (discharge) Day with acidosis (50% <7.35) Daily Sofa score Daily Pregabalin, esketamine, oxycodone Daily NRS/VAS score or BPS/external assessment Score 3x/d >3 / 3x "shows pain"/manipulation Benzodiazepines Total requirement in ICU in mg Haloperidol, clonidine, quetiapine, etc. Per cumulative dose in mg/d Other: Risperidone, Clozapine, Pipamperone Per cumulative dose in mg/day Organ replacement procedures (dialysis, ECMO, ECLS, plasmapheresis) Number of days after organ replacement procedure Deceased on day 28/transferred Transfer/type of discharge

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult patients with Elective cardiac surgery Heart valve surgery, bypass surgery with CPB

Description

Inclusion Criteria:

  • Elective cardiac surgery Heart valve surgery, bypass surgery with CPB
  • Length of stay in ICU > 48 hours
  • Age ≥18 years
  • Fluent German language skills

Exclusion Criteria:

  • Age <18 years
  • Lack of capacity to give consent
  • Emergency
  • Readmission to intensive care unit
  • OPCAB surgery, microsurgical procedure

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

Cohorts and Interventions

Group / Cohort
adults with elective valve or bypass surgery using heart-lung machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients after heart surgery with postoperative delirium
Time Frame: from 48 hours ICU stay to day 10 of ICU stay or dismssal from ICU
Relation between result of MO-FA2-(TB)-Score and actual development of postoperative delirium
from 48 hours ICU stay to day 10 of ICU stay or dismssal from ICU

Collaborators and Investigators

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

Sponsor

University Hospital Tuebingen

Investigators

  • Study Director: Peter Rosenberger, Prof. Dr., Universitaetsklinikum Tuebingen

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 (Estimated)

March 9, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

May 30, 2028

Study Registration Dates

First Submitted

November 28, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Verify-MO-FA2-(TB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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