Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis

NCT03474367 | Unknown

• 1 other identifier: 97/2017
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the cost-effectiveness of unplanned dialysis (peritoneal dialysis and hemodialysis) in chronic kidney disease (CKD) during the first year of therapy in a single center.

Conditions

Cost-effectiveness Analysis; Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

Unplanned Peritoneal Dialysis; Unplanned Hemodialysis; Cost-Benefit Analysis; Dialysis; Peritoneal Dialysis; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Cost effectiveness analysis of unplanned PD and HD at the General Hospital of the School of Medicine of Botucatu (HC-FMB)

  Cost effectiveness analysis of unplanned PD and HD with the data collected at our center

  12 months

Secondary Outcomes (1)

• Cost effectiveness analysis of unplanned PD and HD in national and international scenario

  12 months

Study Arms (2)

Unplanned Peritoneal Dialysis

CKD patients stage 5 (eGFR \< 15 ml/min/1,73m²) or stages 4 with abrupt worsening renal function requiring dialysis treatment immediately, followed or not by nephrologists prior to renal replacement therapy (RRT) indication, that agree to initiate peritoneal dialysis (PD) in less than 48 hours after implantation of the peritoneal catheter, without family training or adequacy of the home. The patient must not have any absolute contraindications to initiate PD, which include: presence of recent abdominal surgery (less than 30 days); multiple previous abdominal surgery (more than two); presence of fibrosis or peritoneal adhesions; fungal peritonitis; severe respiratory insufficiency (FiO2\> 70%); abdominal infections; severe hyperkalemia with changes characteristic in ECG; and acute pulmonary edema. These patients will be treated with HD.

Unplanned Hemodialysis

CKD patients stage 5 (eGFR \< 15 ml/min/1,73m²) or stages 4 with abrupt worsening renal function requiring dialysis treatment immediately, followed or not by nephrologists prior to renal replacement therapy (RRT) indication, that agree to initiate HD without a functional arteriovenous fistula, ie, with a central venous catheter (nontunneled or tunneled).

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

Incident dialysis patients.

You may qualify if:

• Ambulatorial Chronic Kidney Disease patients stage 5 (eGFR \< 15 ml/min) or stages 4 with abrupt worsening requiring dialysis treatment immediately followed or not by nephrologists prior to Renal Replacement Therapy indication.

You may not qualify if:

• Transitions between HD and PD
• Patients with functional arteriovenous fistula entering hemodialysis
• Patients with functional PD access implanted ate least 48h before the first use
• Patient or family trained in PD and/or with the right adequacy of the home

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Hospital das Clínicas da Faculdade de Medicina de Botucatu

Botucatu, São Paulo, 18606-260, Brazil

Location

Related Publications (25)

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  PMID: 26897038 BACKGROUND

• Silva TN, de Marchi D, Mendes ML, Barretti P, Ponce D. Approach to prophylactic measures for central venous catheter-related infections in hemodialysis: a critical review. Hemodial Int. 2014 Jan;18(1):15-23. doi: 10.1111/hdi.12071. Epub 2013 Aug 14.

  PMID: 23944971 BACKGROUND

• Mendes ML, Castro JH, Silva TN, Barretti P, Ponce D. Effective use of alteplase for occluded tunneled venous catheter in hemodialysis patients. Artif Organs. 2014 May;38(5):399-403. doi: 10.1111/aor.12186. Epub 2013 Oct 3.

  PMID: 24117542 BACKGROUND

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  PMID: 21622993 BACKGROUND

• Lobbedez T, Lecouf A, Ficheux M, Henri P, Hurault de Ligny B, Ryckelynck JP. Is rapid initiation of peritoneal dialysis feasible in unplanned dialysis patients? A single-centre experience. Nephrol Dial Transplant. 2008 Oct;23(10):3290-4. doi: 10.1093/ndt/gfn213. Epub 2008 Apr 19.

  PMID: 18424817 BACKGROUND

• Alkatheeri AM, Blake PG, Gray D, Jain AK. Success of Urgent-Start Peritoneal Dialysis in a Large Canadian Renal Program. Perit Dial Int. 2016 Mar-Apr;36(2):171-6. doi: 10.3747/pdi.2014.00148. Epub 2015 Sep 15.

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• Povlsen JV. Unplanned start on assisted peritoneal dialysis. Contrib Nephrol. 2009;163:261-263. doi: 10.1159/000223808. Epub 2009 Jun 3.

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• Htay H, Johnson DW, Craig JC, Teixeira-Pinto A, Hawley CM, Cho Y. Urgent-start peritoneal dialysis versus haemodialysis for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jan 27;1(1):CD012899. doi: 10.1002/14651858.CD012899.pub2.

  PMID: 33501650 DERIVED

• Htay H, Johnson DW, Craig JC, Teixeira-Pinto A, Hawley CM, Cho Y. Urgent-start peritoneal dialysis versus conventional-start peritoneal dialysis for people with chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 15;12(12):CD012913. doi: 10.1002/14651858.CD012913.pub2.

  PMID: 33320346 DERIVED

Related Links

• National Kidney Foundation. 2016
• Danish Nephrology Registry, Annual Report 2011
• Census of the Brazillian Society of Nephrology 2014

Study Design

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

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: March 22, 2018
• Study Start: April 1, 2017
• Primary Completion: March 12, 2020
• Study Completion: December 12, 2021
• Last Updated: October 2, 2019

Record last verified: 2019-09

Locations

BR (1)