Comparison of Myocardial Injury After Noncardiac Surgery (MINS) Incidence in Supine vs. Prone Positioning During Percutaneous Nephrolithotomy (PNL)

NCT06944301 | Not Yet Recruiting DMC

• 1 other identifier: 3211789
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective cohort study aims to compare the incidence of Myocardial Injury after Noncardiac Surgery (MINS) in patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones in supine versus prone positioning. MINS is defined as an elevated postoperative troponin level (≥0.03 ng/mL) within 48 hours after surgery. Approximately 400 patients will be enrolled, with 200 patients in each positioning group (supine and prone). The primary outcome is the incidence of MINS, assessed through troponin measurements and electrocardiogram (ECG) findings. Secondary outcomes include intraoperative complications, duration of surgery, and postoperative recovery metrics. The study seeks to determine whether surgical positioning impacts MINS risk, potentially guiding safer surgical practices.

Conditions

MINS; Myocardial Injury After Noncardiac Surgery; Myocardial Injury After Noncardiac Surgery (MINS); Renal Calculi; Renal Stones; Percutaneous Nephrolithotomy (PNL); Nephrolithiasis

Keywords

MINS; PNL; percutaneous nephrolithotomy; Myocardial Injury after Noncardiac Surgery; prone; supine

Outcome Measures

Primary Outcomes (1)

• Incidence of Myocardial Injury after Noncardiac Surgery (MINS)

  Proportion of patients with postoperative troponin T levels ≥0.03 ng/mL within 48 hours after PNL, confirmed by ECG findings if ischemic changes are present.

  Up to 48 hours post-surgery

Secondary Outcomes (2)

• Surgical Duration

  During surgery.

• Postoperative Hospital Stay

  From surgery to discharge.

Study Arms (2)

Supine PNL

OTHER

Patients undergoing PNL in the supine position.

Diagnostic Test: blood sampling

Prone PNL

OTHER

Patients undergoing PNL in the prone position.

Diagnostic Test: blood sampling

Interventions

blood sampling DIAGNOSTIC_TEST

measuring troponine preoperative and postoperative first and second day

Prone PNL; Supine PNL

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥40 years.
• Patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones.
• Willing and able to provide informed consent.

You may not qualify if:

• Known coronary artery disease, heart failure, or other significant cardiovascular conditions.
• Elevated preoperative troponin levels (≥0.03 ng/mL).
• Major intraoperative complications (e.g., severe bleeding requiring transfusion).
• Inability to comply with study procedures.

Sponsors & Collaborators

• Medipol University: lead
• Istanbul Medipol University Hospital: collaborator

Related Publications (7)

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• Edward GM, Das SF, Elkhuizen SG, Bakker PJ, Hontelez JA, Hollmann MW, Preckel B, Lemaire LC. Simulation to analyse planning difficulties at the preoperative assessment clinic. Br J Anaesth. 2008 Feb;100(2):195-202. doi: 10.1093/bja/aem366.

  PMID: 18211993 BACKGROUND

• POISE Study Group; Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Malaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S0140-6736(08)60601-7. Epub 2008 May 12.

  PMID: 18479744 BACKGROUND

• Chretien AE, Gagnon-Arsenault I, Dube AK, Barbeau X, Despres PC, Lamothe C, Dion-Cote AM, Lague P, Landry CR. Extended Linkers Improve the Detection of Protein-protein Interactions (PPIs) by Dihydrofolate Reductase Protein-fragment Complementation Assay (DHFR PCA) in Living Cells. Mol Cell Proteomics. 2018 Feb;17(2):373-383. doi: 10.1074/mcp.TIR117.000385. Epub 2017 Dec 4.

  PMID: 29203496 BACKGROUND

• Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.

  PMID: 28444280 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis; Deception

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Ali İhsan Memmi, Medical Doctor

CONTACT

+90 537 9220997; alimemmi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share