Morbidity, Mortality, Short and Long-term Survival of Hemodialysis End-stage Kidney Disease Patients in Central Tanzania

NCT03988491 | Unknown DMC

• 1 other identifier: BMH/J:89/30/VOL.X/2020
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: In the last 2 decades, Tanzania made great improvements in the renal replacement therapy infrastructure and services. However, renal replacement therapy remains a challenge in the developing world in terms of inadequate renal registries, and limited published literature. Objectives: This study will identify predictors of mortality, identify common causes of infection and hospitalization, their incidences, prevalence, and time-to-event analysis and analyze short and long-term survival of end-stage renal disease (ESRD) patients on hemodialysis in two hemodialysis centers in Dodoma, Tanzania. Furthermore, this study will establish a registry to be called Tanzania Registry for Chronic Renal Failure (TRCRF). Methodology: This will be a prospective-observational study (Patient registry). It will be conducted in Tanzania, a developing world country involving two hemodialysis centers, namely Benjamin Mkapa Hospital and UDOM Health center, both affiliated with the University of Dodoma. Data will be collected by accessing patients' records receiving hemodialysis due to ESRD in the two centers from September 2019 to September 2024. Patients' demographics, medical history, investigation findings, and hemodialysis adequacy will be extracted as independent outcomes. In contrast, the outcome (i.e., Death) during the follow-up will be extracted as a primary dependent outcome. Binary logistic regression will be applied to come up with statistically significant predictors of deaths. Other outcomes will be incidences, prevalence, and time-to-event analysis of common causes of infection and re-hospitalization. Kaplan-Meier survival curves will be constructed from statistically significant predictors of deaths, and patients' survival at 1, 3, and 5 years will be illustrated.

Conditions

End-Stage Renal Disease

Keywords

Kidney Failure, Chronic; Mortality; Survival; Observational Study; Incidence; Renal Dialysis

Outcome Measures

Primary Outcomes (2)

• mortality

  To identify predictors for mortality among End-stage renal disease patients undergoing maintenance hemodialysis at UDOM (University of Dodoma) health center and Benjamin Mkapa Hospital using by binary logistic regression.

  5 Years

• Survival

  To analyze survival of End-stage renal disease undergoing maintenance hemodialysis at 1, 3 and 5 years, at UDOM health center and Benjamin Mkapa Hospital, using Kaplan-Meier survival curves.

  5 Years

Secondary Outcomes (6)

• Infection incidence

  5 Years

• Infection prevalence

  5 Years

• Time-to-infection survival

  5 Years

• Incidences of rehospitalization

  5 Years

• Prevalence of rehospitalization causes

  5 Years

Study Arms (1)

End stage renal disease on maintanance hemodialysis

End-stage renal disease due to any etiology on maintenance hemodialysis and consented to participate in the study.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

End stage renal disease patients requiring maintanance hemodialysis.

You may qualify if:

• Participants diagnosed with end-stage renal disease due to any etiology.
• Participants initiated on maintenance dialysis.
• Participants attending Benjamin Mkapa Hospital or UDOM health center.
• Eligible participants consented to participate in the study.

You may not qualify if:

• Patients diagnosed with acute kidney injury.
• Patients with CKD stage other than stage 5.
• Patients underwent kidney transplantation.
• Patients on dialysis other than hemodialysis.

Sponsors & Collaborators

• Benjamin Mkapa Hospital: lead

Study Sites (1)

Benjamin Mkapa Hospital

Dodoma, 41218, Tanzania

RECRUITING

Related Publications (20)

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  PMID: 30846291 BACKGROUND

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  PMID: 16014098 BACKGROUND

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  BACKGROUND

• National High Blood Pressure Education Program. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda (MD): National Heart, Lung, and Blood Institute (US); 2004 Aug. Report No.: 04-5230. Available from http://www.ncbi.nlm.nih.gov/books/NBK9630/

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  PMID: 23374329 BACKGROUND

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  PMID: 23162269 BACKGROUND

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  PMID: 30065065 BACKGROUND

• Pauly RP. Survival comparison between intensive hemodialysis and transplantation in the context of the existing literature surrounding nocturnal and short-daily hemodialysis. Nephrol Dial Transplant. 2013 Jan;28(1):44-7. doi: 10.1093/ndt/gfs419.

  PMID: 23300280 BACKGROUND

• Wong B, Ravani P, Oliver MJ, Holroyd-Leduc J, Venturato L, Garg AX, Quinn RR. Comparison of Patient Survival Between Hemodialysis and Peritoneal Dialysis Among Patients Eligible for Both Modalities. Am J Kidney Dis. 2018 Mar;71(3):344-351. doi: 10.1053/j.ajkd.2017.08.028. Epub 2017 Nov 22.

  PMID: 29174322 BACKGROUND

• Aviles-Gomez R, Luquin-Arellano VH, Garcia-Garcia G, Ibarra-Hernandez M, Briseno-Renteria G. Is renal replacement therapy for all possible in developing countries? Ethn Dis. 2006 Spring;16(2 Suppl 2):S2-70-2.

  PMID: 16774015 BACKGROUND

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  PMID: 11887842 BACKGROUND

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  PMID: 26563300 BACKGROUND

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  PMID: 9792082 BACKGROUND

• Meremo AJ, Ngilangwa DP, Mwashambwa MY, Masalu MB, Kapinga J, Tagalile R, Sabi I. Challenges and outcomes of haemodialysis among patients presenting with kidney diseases in Dodoma, Tanzania. BMC Nephrol. 2017 Jul 4;18(1):212. doi: 10.1186/s12882-017-0634-2.

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  PMID: 28532551 BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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 Officials

• Joel D Swai, MMed

  Benjamin Mkapa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joel Swai, MMed

CONTACT

+8618508413470; joel.swai@hotmail.com

Joel Swai, MMed

CONTACT

+255766564522; joel.swai@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician-Internal Medicine Department

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 17, 2019
• Study Start: August 1, 2020
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)