PErfusion QUality ODds

Acute Kidney Injury Clinical Trial

— PEQUOD  

Official title:

Perfusion Quality Odds

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019546
• Other study ID #: PEQUOD
• Status: Recruiting
• Start date: January 23, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: IRCCS Policlinico S. Donato
• Contact: Marco Ranucci, MD
• Phone: 0252774754
• Email: marco.ranucci[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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 which for the present study follows the AKIN criteria. There are different predictive scores for the CSA-AKI based on the patient and surgery-associated parameters. These models could be defined as "static". It's known that a number of CPB-associated parameters could influence CSA-AKI, as well. These include hematocrit (HCT), oxygen delivery (DO2), time of exposure to a critical DO2, and perfusion pressure. These parameters, taken separately, are associated with CSA-AKI development. Recently, our Institution has 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). MDPI has higher discrimination power when compared to the static scores, in the original series and in the internal validation with the Bootstrap technique. The present study validates MDPI in a new prospective series of patients undergoing cardiac surgery with CPB. An enrollment of 400 patients is anticipated with a stopping rule for efficacy at interim analysis (for primary endpoint) at 50% enrollment (200 patients) if the c-statistics for any stage of CSA-AKI reaches at least 0.75. Futility is defined as an AUC of 0.6 or lower.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients requiring preoperative dialysis

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Disease
• Extracorporeal Circulation; Complications
• Heart Diseases
• Perfusion; Complications

Intervention

Other:
• PEQUOD
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.

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	MI

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. 2022 Oct 28:2676591221137033. doi: 10.1177/02676591221137033. Online ahead of print. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with postoperative respiratory insufficiency	P/F ratio > 200 with radiographic evidence of pulmonary distress, if compared to the baseline by an independent radiologist	First 48 postoperative hours
Secondary	Number of patients with postoperative low cardiac output	Use of inotrope drugs for more than 48 hours and/or mechanical support	First 48 postoperative hours
Secondary	Number of patients experiencing postoperative major morbidity	As defined by STS criteria as one or more of the following items: AKI stage 2, stroke, mechanical ventilation duration > 48 hours, sepsis, surgical re-exploration	First 48 postoperative hours
Secondary	Number of patients who needed prolonged ICU stay	ICU stay duration > 4 days	First 4 postoperative days
Secondary	Number of deceased patients	Dead or alive status	30 days after surgery