Leipzig FAST-TRACK Over 15 Years for Cardiac Surgical Patients

Retrospective Analysis of 15 Years of Leipzig "Fast-Track" Concept.

Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. However, promising outcomes led to a more widespread utilization with more complex procedures. The aim of this study is to analyse the fast track evolutions.

Study Overview

• Status: Recruiting
• Conditions: Post-cardiac Surgery

Detailed Description

Fast Track Treatment includes many elements recommended by the ERAS Society for cardiac surgery(1). Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The patients are transferred from the operation room to the recovery room, extubated there within a short time, stabilized and transferred on the same day to intermediate care (IMC). Ideally, the patient will be transferred to the normal ward on the first postoperative day. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. However, promising outcomes led to a more widespread utilization with more complex procedures. The aim of this study is to analyse the evolutions within the fast-track protocol over a period of 15 years (from November 2005 to December 2020).

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

• Study Contact: Name: Waseem Zakhary, Dr.; Phone Number: 0049341865254024; Email: waseemzakariaaziz.zakhary@medizin.uni-leipzig.de
• Study Contact Backup: Name: Joerg Ender, Prof.; Phone Number: 00493418651407; Email: Joerg.ender@medizin.uni-leipzig.de

Study Locations

• Germany
  • Sachsen
    • Leipzig, Sachsen, Germany, 04289
      • Recruiting
      • Leipzig Heart Center
      • Contact: Waseem Zakhary, Dr; Phone Number: 0049341865254024; Email: waseemzakariaaziz.zakhary@medizin.uni-leipzig.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

-All consecutive cardiac surgical patients treatet with Leipzig fast-track protocol

Description

Inclusion Criteria:

• Adults >18y

Exclusion Criteria:

• Incomplete data
• Catheter-valve implantation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FT evolution analysis in complexity	Trends analysis in complexity ( using EUROSCORE II) against time (in years)	Novmber 2005- December 2020
FT evolution analysis in length of stay	Trends analysis of length of stay ( in hospital and ICU in days) against time (in years)	Novmber 2005- December 2020
FT evolution analysis in postoperative complications	Trends analysis in postoperative complications ( cardiac, pulmonary, and neurological) in percentage against time ( in years)	Novmber 2005- December 2020
FT evolution analysis in postoperative mortality rate	Trends analysis of postoperative mortality rate ( in percentage) against time (in years)	Novmber 2005- December 2020

Collaborators and Investigators

• Sponsor: Heart Center Leipzig - University Hospital
• Investigators: Study Chair: Joerg Ender, Leipzig Heart Center

Publications and helpful links

General Publications

• Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
• Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.
• Ender J, Borger MA, Scholz M, Funkat AK, Anwar N, Sommer M, Mohr FW, Fassl J. Cardiac surgery fast-track treatment in a postanesthetic care unit: six-month results of the Leipzig fast-track concept. Anesthesiology. 2008 Jul;109(1):61-6. doi: 10.1097/ALN.0b013e31817881b3.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 16, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Fast track after cardiac surgery; ERAS cardiac surgery
• Other Study ID Numbers: FT15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Retrospective analysis of the data ( collected from the hospital clinical information systems) for all consecutive patients admitted to PACU during 15 years.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No