Expanded hemodialysis registry protocol in Colombia

• Register: ISRCTN
• Last refreshed on: 4 April 2022
• Main ID: ISRCTN45211359
• Date of registration: 16/08/2017
• Prospective Registration: Yes
• Primary sponsor: Baxter Healthcare Corporation
• Public title: Expanded hemodialysis registry protocol in Colombia
• Scientific title: Expanded hemodialysis registry protocol in Colombia (COREXH): a prospective cohort, multicenter, observational study
• Date of first enrolment: 04/09/2017
• Target sample size: 1000
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN45211359
• Study type: Observational
• Study design: Prospective cohort multicenter observational study (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Colombia

Contacts

• Name: Mauricio Sanabria Arenas

Key inclusion & exclusion criteria

Inclusion criteria:
1. The subject or a legally authorized representative has signed the written informed consent form
2. The subject is = 18 years old
3. The subject has been diagnosed with CKD with more than 90 days in chronic hemodialysis
4. The subject has been receiving expanded hemodialysis treatment in a renal clinic of the RTS network with the Theranova® dialyzer
5. The subject has been undergoing a hemodialysis schedule at least 3 times per week and a minimum duration of 4 hours per session
6. The subject is being dialyzed in a renal clinic that meets water quality standards established by the Association for the Advancement of Medical Instrumentation (AAMI)

Exclusion criteria:
1. The subject has a life expectancy of no more than six months as determined by his/her attending physician
2. The subject has or had an active infection diagnosed in the past 4 weeks


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

End stage renal disease with hemodialysis
Urological and Genital Diseases

Intervention(s)

The study data will be exported directly from the patient’s electronic medical record system (Versia®) by Renal Therapy Services. The study data that normally do not belong to the patient’s Versia record shall be entered by the center’s staff to an Excel sheet with a default format.

Demographic, clinical characteristics data and clinical outcome:
1. Demographic variables: identification of the subject within the study, date of birth, age, sex
2. Medical history variables: cause of the chronic kidney disease (CKD), prior hypertension diagnosis, prior diabetes diagnosis, prior cardiovascular disease diagnosis, Charlson Index adapted to CKD, Karnofsky performance status scale, date of initiation of chronic renal replacement therapy and vintage in dialysis therapy
3. Hemodialysis variables: hemodialysis session duration, number of sessions per week, dialysis machine name, hemodialysis machine technology used, blood flow velocity (QB), dialysate liquid velocity (QD), ultrafiltration, pre-dialysis weight, post-dialysis weight, dry weight, type of vascular access, type of extracorporeal circuit anticoagulation. Total volume of blood treated, systolic blood pressure , diastolic blood pressure , heart rate, respiratory rate, temperature. They will be taken for each session
4. Laboratory variables: the measure frequency is adjusted to RTS Colombia’s clinical practice standards: hemoglobin, hematocrit, platelets, lymphocytes, potassium, calcium, phosphorus, albumin, pre and post BUN, pre and post Urea, single pool Kt/V, ferritin, iron, transferrin saturation percentage, TIBC, UIBC, PTHi, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, ultra-sensitive CRP, residua

Primary Outcome(s)

Effectiveness assessments:
1. The rates of hospitalization and hospital days
2. Mortality rates
3. Rates of non-fatal cardiovascular events
Exported directly from the patient’s electronic medical record system; the follow-up is 1 year.

Secondary Outcome(s)

1. Patient-reported outcome measures: individual item scores and total scores for Dialysis Symptom Index (DSI) and quality of life (KDQOL-36™) and frequency of restless legs diagnosis
2. Number of uses of phosphorus chelating agents and plasma phosphorus level
3. ESA dose, type and route of administration and hemoglobin level
4. Number of antihypertensive drugs and systolic and diastolic blood pressure
5. Intake of tablets/pills per day and KDQOL-36™ Score
6. Use of nutritional supplements and nutritional status
Exported directly from the patient’s electronic medical record system; the follow-up is 1 year.

Secondary ID(s)

RTSCOL003

Source(s) of Monetary Support

Baxter Healthcare Corporation

Ethics review

Status:
Approval date:
Contact:

Clinical research ethics committee of Renal Therapy Services, 01/08/2017, ref: 007

Results

• Results available: Yes
• Date Completed: 30/12/2018