PErfusion QUality ODds

NCT06019546 | Unknown

• 1 other identifier: PEQUOD
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac surgery-associated acute kidney injury (CSA-AKI) is a frequent complication after cardiac operations with cardiopulmonary bypass (CPB) use. Its frequency varies depending on the severity grade. There are different "static" predictive scores for the CSA-AKI based on the patient and surgery-associated parameters. Recently, in our Institution was developed a predictive algorithm for CSA-AKI that starts with a static model and then integrated with 7 CPB-associated parameters: HCT, DO2, time of exposure to a critical DO2, systemic pressure, CPB duration time, lactate value, transfusion of red blood cells (RBC), that together build a dynamic perfusion risk (DPR) associated to the CPB. Combining the static and dynamic models produces the Multifactorial Dynamic Perfusion Index (MDPI). The present study validates MDPI in a new prospective series of patients undergoing cardiac surgery with CPB.

Conditions

Cardiac Disease; Extracorporeal Circulation; Complications; Perfusion; Complications; Acute Kidney Injury

Keywords

acute kidney injury; cardiopulmonary bypass; cardiac surgery; risk score

Outcome Measures

Primary Outcomes (1)

• Number of patients with postoperative acute kidney injury

  Occurence of any stage acute kidney injury as defined by the AKIN criteria

  First 48 postoperative hours

Secondary Outcomes (5)

• Number of patients with postoperative respiratory insufficiency

  First 48 postoperative hours

• Number of patients with postoperative low cardiac output

  First 48 postoperative hours

• Number of patients experiencing postoperative major morbidity

  First 48 postoperative hours

• Number of patients who needed prolonged ICU stay

  First 4 postoperative days

• Number of deceased patients

  30 days after surgery

Study Arms (1)

PEQUOD

Patients undergoing cardiac surgery with cardiopulmonary bypass whose parameters of interest will be registered during cardiopulmonary bypass by the Livanova BE-CAPTA monitor.

Other: PEQUOD

Interventions

PEQUOD OTHER

During cardiopulmonary bypass registration of the parameters of interest by the Livanova BE-CAPTA monitor. After surgery, registration of creatinine values up to 48 postoperative hours.

PEQUOD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in our Institution for a scheduled cardiac surgery with cardiopulmonary bypass

You may qualify if:

• patients undergoing cardiac surgery with cardiopulmonary bypass
• age of 18 years and higher
• willingness to participate and sign the informed consent

You may not qualify if:

• \- patients requiring preoperative dialysis

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

RECRUITING

Related Publications (11)

• Ranucci M, Aloisio T, Cazzaniga A, Di Dedda U, Gallazzi C, Pistuddi V. Validation of renal-risk models for the prediction of non-renal replacement therapy cardiac surgery-associated acute kidney injury. Int J Cardiol. 2018 Dec 1;272:49-53. doi: 10.1016/j.ijcard.2018.07.114. Epub 2018 Jul 24.

  PMID: 30078648 BACKGROUND

• Thakar CV, Arrigain S, Worley S, Yared JP, Paganini EP. A clinical score to predict acute renal failure after cardiac surgery. J Am Soc Nephrol. 2005 Jan;16(1):162-8. doi: 10.1681/ASN.2004040331. Epub 2004 Nov 24.

  PMID: 15563569 BACKGROUND

• Mehta RH, Grab JD, O'Brien SM, Bridges CR, Gammie JS, Haan CK, Ferguson TB, Peterson ED; Society of Thoracic Surgeons National Cardiac Surgery Database Investigators. Bedside tool for predicting the risk of postoperative dialysis in patients undergoing cardiac surgery. Circulation. 2006 Nov 21;114(21):2208-16; quiz 2208. doi: 10.1161/CIRCULATIONAHA.106.635573. Epub 2006 Nov 6.

  PMID: 17088458 BACKGROUND

• Wijeysundera DN, Karkouti K, Dupuis JY, Rao V, Chan CT, Granton JT, Beattie WS. Derivation and validation of a simplified predictive index for renal replacement therapy after cardiac surgery. JAMA. 2007 Apr 25;297(16):1801-9. doi: 10.1001/jama.297.16.1801.

  PMID: 17456822 BACKGROUND

• Swaminathan M, Phillips-Bute BG, Conlon PJ, Smith PK, Newman MF, Stafford-Smith M. The association of lowest hematocrit during cardiopulmonary bypass with acute renal injury after coronary artery bypass surgery. Ann Thorac Surg. 2003 Sep;76(3):784-91; discussion 792. doi: 10.1016/s0003-4975(03)00558-7.

  PMID: 12963200 BACKGROUND

• Habib RH, Zacharias A, Schwann TA, Riordan CJ, Durham SJ, Shah A. Adverse effects of low hematocrit during cardiopulmonary bypass in the adult: should current practice be changed? J Thorac Cardiovasc Surg. 2003 Jun;125(6):1438-50. doi: 10.1016/s0022-5223(02)73291-1.

  PMID: 12830066 BACKGROUND

• Ranucci M, Romitti F, Isgro G, Cotza M, Brozzi S, Boncilli A, Ditta A. Oxygen delivery during cardiopulmonary bypass and acute renal failure after coronary operations. Ann Thorac Surg. 2005 Dec;80(6):2213-20. doi: 10.1016/j.athoracsur.2005.05.069.

  PMID: 16305874 BACKGROUND

• Ranucci M, Johnson I, Willcox T, Baker RA, Boer C, Baumann A, Justison GA, de Somer F, Exton P, Agarwal S, Parke R, Newland RF, Haumann RG, Buchwald D, Weitzel N, Venkateswaran R, Ambrogi F, Pistuddi V. Goal-directed perfusion to reduce acute kidney injury: A randomized trial. J Thorac Cardiovasc Surg. 2018 Nov;156(5):1918-1927.e2. doi: 10.1016/j.jtcvs.2018.04.045. Epub 2018 Apr 18.

  PMID: 29778331 BACKGROUND

• Rasmussen SR, Kandler K, Nielsen RV, Cornelius Jakobsen P, Knudsen NN, Ranucci M, Christian Nilsson J, Ravn HB. Duration of critically low oxygen delivery is associated with acute kidney injury after cardiac surgery. Acta Anaesthesiol Scand. 2019 Nov;63(10):1290-1297. doi: 10.1111/aas.13457. Epub 2019 Sep 10.

  PMID: 31436307 BACKGROUND

• de la Hoz MA, Rangasamy V, Bastos AB, Xu X, Novack V, Saugel B, Subramaniam B. Intraoperative Hypotension and Acute Kidney Injury, Stroke, and Mortality during and outside Cardiopulmonary Bypass: A Retrospective Observational Cohort Study. Anesthesiology. 2022 Jun 1;136(6):927-939. doi: 10.1097/ALN.0000000000004175.

  PMID: 35188970 BACKGROUND

• Ranucci M, Di Dedda U, Cotza M, Zamalloa Moreano K. The multifactorial dynamic perfusion index: A predictive tool of cardiac surgery associated acute kidney injury. Perfusion. 2024 Jan;39(1):201-209. doi: 10.1177/02676591221137033. Epub 2022 Oct 28.

  PMID: 36305847 BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Marco Ranucci, MD

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Ranucci, MD

CONTACT

0252774754; marco.ranucci@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Cardiovascular Anesthesia and Intensive Care Department

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: August 31, 2023
• Study Start: January 23, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)