Clinical Outcomes of Hemodialysis in Brazil (COHEBRA): a Prospective Cohort Study

NCT05273424 | Enrolling By Invitation

• 1 other identifier: COHEBRA
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Chronic kidney disease (CKD) is characterized by progressive decrease in glomerular filtration rate (GFR), eventually reaching the end-stage renal disease (ESRD) requiring renal replacement therapy (RRT). The decrease in GFR is associated with a linear increase in cardiovascular mortality. Dysfunction of the autonomic nervous system (ANS) has been well documented in patients with CKD, especially in people with ESRD. The renal ischemia causes both the excessive activation of the renin-angiotensin-aldosterone system (RAAS) by increasing renin release, as sympathetic ANS, through the afferent sympathetic nerves. The overactivated RAAS and sympathetic SNA feedback each other, which contributes to cardiovascular disease (CVD) in CKD. Despite the involvement of these systems in the pathogenesis of CVD in CKD, drugs that block the RAAS or sympathetic SNA have shown heterogeneous effects in CVD in this population. A potential explanation is the genetic heterogeneity, such as the polymorphism in the gene for angiotensin converting enzyme (ACE).In addition, the inflammatory process associated with CKD is regarded as central player in the general degenerative changes backing CKD on HD shorter survival, which in many aspects is like accelerated aging. Skeletal muscles are also affected in a pattern like aging sarcopenia, with loss of function and mass. Objectives: to evaluate the impact of ECA gene polymorphism, HRV, body composition, functional capacity, muscle strength, inflammatory factors and other potential predictors on the survival of patients with CKD treated by HD in a single center in southern Brazil. Methodology: Prospective cohort study. The sample will consist of adult patients with CKD on HD longer than 90 days. Sociodemographic and clinical data is collected from clinical records. HRV analysis is performed using a Micromed@ electrocardiogram device® with a recording of the standard deviation of all normal intervals (SDNN), square root of the mean of the squares of the differences between consecutive intervals (RMSSD), low frequency band (LF) and high frequency (HF) after a midweek HD session. The polymorphism of the ECA gene was evaluated by polymerase chain reaction method in peripheral blood DNA sample. Muscle quality and thickness has been obtained by ultrasound. Functional capacity by 6-minute walking test and muscle strength by dynamometer. The data will be analyzed using Stata 15.0 statistical package.

Conditions

Chronic Kidney Diseases; Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

• survival

  survival time

  ten years

Secondary Outcomes (1)

• hospital admission

  ten years

Study Arms (1)

no groups

A cohort of CKD patients on hemodialysis

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

Adult chronic kidney disease on hemodialysis

You may qualify if:

• chronic kidney disease
• hemodialysis treatment for longer than 90 days

You may not qualify if:

• According to outcomes evaluated

Sponsors & Collaborators

• Catholic University of Pelotas: lead
• Federal University of Pelotas: collaborator

Study Sites (1)

Hospital Universitário São Francisco de Paula

Pelotas, Rio Grande do Sul, 96020-260, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: March 10, 2022
• Study Start: June 1, 2017
• Primary Completion: June 1, 2021
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 10, 2022

Record last verified: 2022-02

Locations

BR (1)