Endothelial Glycocalyx Damage in Acute Kidney Injury

NCT05471583 | Unknown

• 1 other identifier: KCH19-107
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract Significance: Cardiac surgery-associated acute kidney injury (CSA-AKI) is common and has serious immediate and long-term sequelae. Better early prediction of those at highest risk and greater understanding of underlying pathological processes are needed to prevent or minimise damage. Hypotheses

• Dynamic changes in systemic endothelial glycocalyx (Glx) and microcirculatory parameters during coronary artery bypass graft (CABG) surgery are predictive of CSA-AKI.
• Mechanisms for Glx degradation during CABG surgery are akin to those during sepsis Aims
• Investigate Glx and microcirculatory health throughout CABG surgery and recovery and their association with CSA-AKI.
• Explore association between inflammation and Glx degradation during CABG surgery. Methodology
• Prospective cohort study: serial sampling and microcirculatory perfusion imaging of 70 patients undergoing CABG surgery with evaluation of CSA-AKI predictors, including plasma Syndecan-1.
• Examination of inflammation and cardiometabolic proteome and association with vascular changes
• In vitro mechanistic assessment of Glx degradation and relative timing of organelle exocytosis in cultured endothelial cells in response to patient serum, targeting identified candidate mediators.

Conditions

Coronary Artery Disease; Acute Kidney Injury

Keywords

endothelial glycocalyx; microvascular perfusion

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury

  as per Kidney Disease Improving Global Outcomes (KDIGO) guidelines

  7 days

Secondary Outcomes (5)

• thrombomodulin change

  through study completion: 24 hours

• NephroCheck

  1 hour post-op

• Syndecan-1 change

  through study completion: 24 hours

• microvascular flow index

  up to 1 hour post-op

• perfused vessel density

  up to 1 hour post-op

Study Arms (1)

Main group

There is only one group in the study. It is observational.

Other: Main group

Interventions

Main group OTHER

no intervention; observational only

Main group

Eligibility Criteria

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

Study Population

Adults scheduled to undergo CABG at King's College Hospital (KCH)

You may qualify if:

• Listed for CABG surgery with or without CPB, age \>18 years, able and willing to give written informed consent.

You may not qualify if:

• Unable / unwilling to provide blood samples or undergo IDF imaging, cross-clamp fibrillation technique, already on renal replacement therapy

Sponsors & Collaborators

• King's College London: lead
• King's College Hospital NHS Trust: collaborator
• British Heart Foundation: collaborator

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, serum, (spun urine)

MeSH Terms

Conditions

Coronary Artery Disease; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Jennifer Joslin, MA(Oxon) MBBS

CONTACT

07970766125; jennifer.joslin@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: July 25, 2022
• Study Start: November 16, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)