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Status unknownNCT05285098Updated Mar 17, 2022

Leipzig FAST-TRACK Over 15 Years for Cardiac Surgical Patients

An observational study in Post-cardiac Surgery, sponsored by Heart Center Leipzig - University Hospital. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-17.

Sponsored by Heart Center Leipzig - University Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
20,000
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the 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).

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Conditions studied

  • Post-cardiac Surgery

Keywords

  • Fast track after cardiac surgery
  • ERAS cardiac surgery
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In context

Lead sponsor

Heart Center Leipzig - University Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Adults >18y

Exclusion criteria

Exclusion Criteria:

  • Incomplete data
  • Catheter-valve implantation
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
20,000 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. FT evolution analysis in complexity

    Trends analysis in complexity ( using EUROSCORE II) against time (in years)

    Time frame: Novmber 2005- December 2020

  2. FT evolution analysis in length of stay

    Trends analysis of length of stay ( in hospital and ICU in days) against time (in years)

    Time frame: Novmber 2005- December 2020

  3. FT evolution analysis in postoperative complications

    Trends analysis in postoperative complications ( cardiac, pulmonary, and neurological) in percentage against time ( in years)

    Time frame: Novmber 2005- December 2020

  4. FT evolution analysis in postoperative mortality rate

    Trends analysis of postoperative mortality rate ( in percentage) against time (in years)

    Time frame: Novmber 2005- December 2020

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. PubMed 18580173 ↗
  • 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. PubMed 31054241 ↗
  • 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. PubMed 27616189 ↗

Individual participant data

Plan to share: Undecided — Retrospective analysis of the data ( collected from the hospital clinical information systems) for all consecutive patients admitted to PACU during 15 years.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05285098
Lead sponsor
Heart Center Leipzig - University Hospital
Responsible party
Sponsor
First posted
Mar 17, 2022
Start date
Apr 1, 2021
Primary completion
Aug 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Mar 17, 2022

Study contacts

Waseem Zakhary, Dr.
Contact
waseemzakariaaziz.zakhary@medizin.uni-leipzig.de
0049341865254024
Joerg Ender, Prof.
Contact
Joerg.ender@medizin.uni-leipzig.de
00493418651407
Joerg Ender
study chair · Leipzig Heart center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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