Mitochondrial Health and Hemodynamic Instability Related to Renal Replacement Therapy in Critically Ill Patients

NCT05264285 | Unknown

• 1 other identifier: 20200699-01H
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Renal replacement therapy is a life-saving treatment for patients who have sudden and severe kidney failure. However, some of these patients blood pressure who receive this treatment could become unstable, thus resulting in more injuries to their kidneys and may limit the ability of kidney recovery. In order to mitigate the instability in blood pressure, the mitochondrial functions should be studied. Mitochondria are organelles within our bodies' cells that serve as the main source of energy for cell function. Kidney cells have many of these organelles and when they are damaged, it could contribute to kidney disease. At this time, it is not known whether boosting mitochondria health and function in humans could reduce the harm of instability in blood pressure. This research study is being done to try to explore the impact of HIRRT on mitochondria health and kidney recovery by assessing critically ill patients with AKI who are undergoing SLED treatment in ICU at The Ottawa Hospital.

Conditions

Acute Kidney Injury (AKI)

Keywords

Renal replacement therapy (RRT); Slow low-efficiency dialysis (SLED); Metabolites; Nicotinamide adenine dinucleotide (NAD+); Hemodynamic instability related to RRT (HIRRT); Intensive care unit (ICU)

Outcome Measures

Primary Outcomes (1)

• Change in mean arterial pressure (MAP)

  Decline in MAP \>=20 mmHg from the start of SLED or initiation of/increased dose of vasopressors required during SLED, occurring once or more during the SLED session.

  24 months

Secondary Outcomes (1)

• Frequency of HIRRT

  24 months

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

AKI patients who are treated with SLED in ICU.

You may qualify if:

• \>/=18 years;
• Diagnosis of stage 3 AKI per Kidney Disease Improving Global Outcomes (KDIGO) AKI guidelines;
• Starting SLED as first RRT received during current hospitalization.

You may not qualify if:

• Prior kidney transplant;
• Prior nephrectomy;
• Any RRT in the previous year;
• Baseline estimated glomerular filtration rate (eGFR) \<15ml/min/1.73m2.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• University of Ottawa: collaborator
• University of Helsinki: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K2G 2H1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biological specimen collection of pre-and post-dialysis blood samples for up to 5 consecutive SLED treatments. Dialysate samples will be collected from the first 30 patients' initial SLED treatments.

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

Central Study Contacts

Jennifer Kong, MPH

CONTACT

613-738-8400; jkong@toh.ca

Study Design

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

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: March 3, 2022
• Study Start: December 6, 2021
• Primary Completion: December 1, 2023
• Study Completion: September 30, 2024
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

CA (1)