Perioperative Sitagliptin Medication for Reduction of the Inflammatory Response Associated With Cardiopulmonary Bypass

NCT05725798 | Completed

• 1 other identifier: 02-AnIt-19
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Sitagliptin is an inhibitor of the enzyme dipeptidylpeptidase-4 (DPP-4) and represents an established drug in type 2 diabetes mellitus treatment. However, Sitagliptin may also have several antiinflammatory properties. Within this study the investigators examine the effects of perioperative Sitagliptin intake on the inflammatory response after cardiopulmonary bypass.

Conditions

Systemic Inflammatory Response Syndrome

Keywords

SIRS, Cardiac surgery, DPP4

Outcome Measures

Primary Outcomes (2)

• Total norepinephrine-requirement within 24 hours after surgery

  Retrospective data collection from the hospital information system

  Retrospective data collection 24 hours after surgery

• Total crystalloid volume-requirement within 24 hours after surgery

  Retrospective data collection from the hospital information system

  Retrospective data collection 24 hours after surgery

Secondary Outcomes (3)

• Immune cells surface markers

  Measured 24 hours after surgery

• Cytokine-levels

  Measured 24 hours after surgery

• Sublingual microcirculatory parameters: Total vessel density, Proportion of Perfused Vessels, Perfused Vessel Density, Microvascular Flow Index

  Measured immediately after surgery and 24 hours after surgery

Study Arms (3)

DM and Sitagliptin treatment

Cardiac surgery patients who suffer from diabetes mellitus type 2 and take Sitagliptin.

Drug: Sitagliptin

DM without Sitagliptin treatment

Cardiac surgery patients who suffer from diabetes mellitus type 2 and do not take Sitagliptin.

No DM

Cardiac surgery patients who do not suffer from diabetes mellitus type 2 and do not take Sitagliptin.

Interventions

Sitagliptin DRUG

Group 1 who regularly takes Sitagliptin due to diabetes mellitus type 2 continues the treatment perioperatively. Group 2 and group 3 do not take Sitagliptin.

DM and Sitagliptin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult cardiac surgery patients from University Hospital Münster who suffer from... * Diabetes mellitus type 2 with Sitagliptin treatment or, * Diabetes mellitus type 2 without Sitagliptin treatment or, * No diabetes mellitus

You may qualify if:

• Age \>18 years
• Patients undergoing cardiac surgery with use of CBP and...
• Diabetes mellitus type 2 with Sitagliptin treatment or,
• Diabetes mellitus type 2 without Sitagliptin treatmet or,
• No diabetes mellitus
• Written informed consent

You may not qualify if:

• Diabetes mellitus type 1
• Treatment with another DPP4-inhibitor
• Treatment with GLP-1-analoga
• Emergency surgery
• Chronic or acute infection
• Pregnancy
• Participation in an interventional study trial within last 3 months
• Relationship to study investigators

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

University Hospital Münster

Münster, North Rhine-Westphalia, 48147, Germany

Location

Related Publications (4)

• Wrenger S, Kahne T, Bohuon C, Weglohner W, Ansorge S, Reinhold D. Amino-terminal truncation of procalcitonin, a marker for systemic bacterial infections, by dipeptidyl peptidase IV (DP IV). FEBS Lett. 2000 Jan 21;466(1):155-9. doi: 10.1016/s0014-5793(99)01779-2.

  PMID: 10648832 BACKGROUND

• Brabenec L, Muller M, Hellenthal KEM, Karsten OS, Pryvalov H, Otto M, Holthenrich A, Matos ALL, Weiss R, Kintrup S, Hessler M, Dell'Aquila A, Thomas K, Nass J, Margraf A, Nottebaum AF, Rossaint J, Zarbock A, Vestweber D, Gerke V, Wagner NM. Targeting Procalcitonin Protects Vascular Barrier Integrity. Am J Respir Crit Care Med. 2022 Aug 15;206(4):488-500. doi: 10.1164/rccm.202201-0054OC.

  PMID: 35699655 BACKGROUND

• Sablotzki A, Friedrich I, Muhling J, Dehne MG, Spillner J, Silber RE, Czeslik E. The systemic inflammatory response syndrome following cardiac surgery: different expression of proinflammatory cytokines and procalcitonin in patients with and without multiorgan dysfunctions. Perfusion. 2002 Mar;17(2):103-9. doi: 10.1177/026765910201700206.

  PMID: 11958300 BACKGROUND

• Hellenthal KEM, Kintrup S, Wirth T, Brabenec L, Cursiefen C, Beulen R, Hollmann K, Lehmann M, Burkard P, Roth J, Schughart K, Klotz L, Rossaint J, Meybohm P, Wagner NM. DPP4 inhibition curbs systemic inflammation. Crit Care. 2025 Aug 15;29(1):359. doi: 10.1186/s13054-025-05599-x.

  PMID: 40817204 DERIVED

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Nana-Maria Wagner, Prof. Dr.

  University Hospital Münster

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 13, 2023
• Study Start: February 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 22, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)