Leipzig FAST-TRACK Over 15 Years for Cardiac Surgical Patients

Post-cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05285098
• Other study ID #: FT15
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Heart Center Leipzig - University Hospital
• Contact: Waseem Zakhary, Dr.
• Phone: 0049341865254024
• Email: waseemzakariaaziz.zakhary[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults >18y

Exclusion Criteria:

• Incomplete data

• Catheter-valve implantation

Related Conditions & MeSH terms

• Post-cardiac Surgery

Locations

Country	Name	City	State
Germany	Leipzig Heart center	Leipzig	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
Heart Center Leipzig - University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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:CD003587. doi: 10.1002/14651858.CD003587.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FT evolution analysis in complexity	Trends analysis in complexity ( using EUROSCORE II) against time (in years)	Novmber 2005- December 2020
Primary	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
Primary	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
Primary	FT evolution analysis in postoperative mortality rate	Trends analysis of postoperative mortality rate ( in percentage) against time (in years)	Novmber 2005- December 2020