The Effects of Oxiris on Systemic Inflammation and Endothelial dysFunction

NCT04257006 | Unknown

• 1 other identifier: 1BAX-2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

CS-AKI occurring in 20% to 70% of cases depending of the type of cardiac surgery. The systemic inflammatory response is often observed and associated with increased risk of AKI. Cardiopulmonary bypass (CPB) induces a complex inflammatory response that has a multifactorial pathogenesis. The inflammatory response is triggered by exposure of the blood to artificial surfaces during extracorporeal circulation, ischemia/reperfusion injuries, translocation of gram-negative bacteria from the intestinal tract, small amounts of LPS in IV solutions. SIRS during CPB with high levels of inflammatory mediators, active complement proteins and LPS provoke endothelial dysfunction- retraction of endothelial cells with increasing vascular permeability and thrombogenic activity, also inflammatory mediators activate leukocytes and they enhance vascular permeability by affecting endothelial cells and vascular basement membrane. The systemic inflammation and endothelial dysfunction are the basis for multiple organ dysfunction syndrome. Vascular integrity damage during cardiac surgery entail redistribution of fluids with interstitial fluid accumulation and require accurate volume control (pertinent removal of "CPB priming volume"), especially in patients with CKD (low GFR) with high risks of AKI.

Conditions

Acute Kidney Injury Due to Circulatory Failure (Disorder)

Keywords

acute kidney injury

Outcome Measures

Primary Outcomes (1)

• Patient volume status assessment in perioperative period

  To compare volume status in two arms based on CVP mmH2O and PAWP mmHg measurements

  in 24 hours

Secondary Outcomes (2)

• survival after cardiac surgery

  in 90 day

• 'ICU and hospital length of stay after cardiac surgery.

  in 28 days

Study Arms (2)

patients undergoing CRRT with oXiris membrane

EXPERIMENTAL

Elective cardiac surgery patients undergoing CPB we will range in 2 groups: I- with Prismaflex set oXiris (SCUF) after CPB, II- standard protocol. Indications for CRRT (SCUF) with oXiris after ICU admission: 1\. Signs of pulmonary edema after cardiac surgery, verified with X-ray control. Or high risk of pulmonary edema after cardiac surgery: 1. Fluid overload ≥ 10%, measured with equation (%fluid overload= ((total fluid in- total fluid out)/admission body weight\*100) 2. CVP (central venous pressure) ˃ 12 mm H2O. 3. PAWP (pulmonary arterial wedge pressure) ˃ 12 mm Hg, measured by Swan-Ganz catheter. In this arm the treatment of fluid overload will be provided via SCUF with oxiris membrane

Device: oXiris membrane

standard protocol

NO INTERVENTION

Elective cardiac surgery patients undergoing CPB we will range in 2 groups: I- with Prismaflex set oXiris (SCUF) after CPB, II- standard protocol. Indications for CRRT (SCUF) with oXiris after ICU admission: 1\. Signs of pulmonary edema after cardiac surgery, verified with X-ray control. Or high risk of pulmonary edema after cardiac surgery: 1. Fluid overload ≥ 10%, measured with equation (%fluid overload= ((total fluid in- total fluid out)/admission body weight\*100) 2. CVP (central venous pressure) ˃ 12 mm H2O. 3. PAWP (pulmonary arterial wedge pressure) ˃ 12 mm Hg, measured by Swan-Ganz catheter. In this arm the management of fluid overload will be provided via diuretics or IHD (in condition diuretics treatment resistance)

Interventions

oXiris membrane DEVICE

Open heart surgery patients in early postoperative period with clinical signs of fluid overload undergoing CRRT

patients undergoing CRRT with oXiris membrane

Eligibility Criteria

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

You may qualify if:

• elective cardiac surgery patients undergoing CPB (\>60 minutes) with valve replacement and CABG.

You may not qualify if:

• Immunosuppressive therapy, CKD 4 and 5 stages, RRT in last 90 days, pregnancy, autoimmune disease, allergy to heparin.

Sponsors & Collaborators

• St. Petersburg State Pavlov Medical University: lead

Study Sites (1)

Pavlov First St. Petersburg State Medical University

Saint Petersburg, Russsia, 197022, Russia

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Officials

• Yury Polushin, PhD

  Pavlov First St. Petersburg State Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yury Polushin, PhD

CONTACT

+7 (812) 338-66-49; polushin1@gmail.com

Dmitry Sokolov, MD

CONTACT

+7(911)7193333; sokolovdv82@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: February 5, 2020
• Study Start: August 17, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 1, 2022
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: data will be available within 1 year of study completion
• Access Criteria: data access request will be reviewed by an external independent review panel.

Locations

RU (1)