NCT02646436

Brief Summary

Peritoneal dialysis (PD) has become a well-established complementary alternative to haemodialysis (HD) as first-line renal replacement modality. At department of Botucatu Medical School, more than 60% of the chronic kidney disease (CKD) stage 5 patients are started urgently on chronic dialysis due to late referral or unexpected deterioration of residual renal function. These patients, although suitable for PD, were previously started on HD using central venous catheter. Since July 2014 patients have been offered urgent start on chronic PD right after PD-catheter insertion by percutaneous surgery, using Seldinger technique. The main objective is to compare technique and patients survival on unplanned PD vs. unplanned HD in the first 180 days. Methodology: Quasi experimental study which will describe how acute PD will initiated using high volume PD until metabolic and fluid control right after (\<48 h) PD catheter placement standard prescription for a 12 h overnight automatic PD until hospital discharge and intermittent PD at dialysis unit family training.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 15, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

December 15, 2015

Last Update Submit

November 11, 2017

Conditions

Disorders Associated With Peritoneal Dialysis

Keywords

unplanned peritoneal dialysisunplanned heamodialysis

Outcome Measures

Primary Outcomes (1)

  • Comparasion of patients survival between unplanned PD vs. unplanned HD

    The main objective of this study is to compare patients survival on unplanned PD vs. unplanned HD in the first 180 days of therapy

    180 days

Secondary Outcomes (3)

  • Comparasion of hospitalization between unplanned PD vs. unplanned HD

    180 days

  • Comparasion of mechanical complications (%) between unplanned PD vs. unplanned HD

    180 days

  • Comparasion of infectious complications (%) between unplanned PD vs. unplanned HD

    180 days

Other Outcomes (1)

  • Evaluate the increase of PD penetration rate among incident patients initiating chronic dialysis therapy (%)

    Two years

Study Arms (2)

HD treatment

OTHER

Patients with absolute contraindication to the PD method - 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 EKG; and acute pulmonary edema - will be treated with HD.

Other: HD treatment

PD treatment

OTHER

Patients stage 5 (creatinine clearance \< 15 ml/min) requiring dialysis treatment immediately without absolute contraindication to the PD method will receive unplanned PD treatment. High volume PD (HVPD) will be used during the first 7 days of PD in order to achieve metabolic and fluid control. The procedure for acute PD has been published recently by our team . At this point, patients will be discharged from hospital and they will be treated by intermitent PD at the dialysis unit of the University Hospital.until their family be trained and home be prepared for the implementation of technique.

Other: PD treatment

Interventions

HD treatmentOTHER

Patients with absolute contraindication to the PD method will be treated with HD. HD will be performed after implantation of central venous catheter using Seldinger technique by nephrology team.

HD treatment
PD treatmentOTHER

Patients without absolute contraindication to the PD method will be treated with PD. PD will be performed after implantation of peritoneal catheter using Seldinger technique by nephrology team.

PD treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Presence of recent abdominal surgery (less than 30 days)
  • Multiple previous abdominal surgery (more than two)
  • Severe respiratory insufficiency (FiO2\> 70%)
  • Abdominal infections
  • Severe hyperkalemia with changes characteristic in EKG
  • Acute pulmonary edema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paulista State University "Júlio de Mesquita Filho"

Botucatu, São Paulo, 18618687, Brazil

RECRUITING

Related Publications (12)

  • Ponce D, Buffarah MB, Goes C, Balbi A. Peritoneal Dialysis in Acute Kidney Injury: Trends in the Outcome across Time Periods. PLoS One. 2015 May 12;10(5):e0126436. doi: 10.1371/journal.pone.0126436. eCollection 2015.

    PMID: 25965868BACKGROUND

  • Pajek J. Overcoming the Underutilisation of Peritoneal Dialysis. Biomed Res Int. 2015;2015:431092. doi: 10.1155/2015/431092. Epub 2015 Nov 11.

    PMID: 26640787BACKGROUND

  • Ivarsen P, Povlsen JV. Can peritoneal dialysis be applied for unplanned initiation of chronic dialysis? Nephrol Dial Transplant. 2014 Dec;29(12):2201-6. doi: 10.1093/ndt/gft487. Epub 2013 Dec 17.

    PMID: 24353321BACKGROUND

  • Lecouf A, Ryckelynck JP, Ficheux M, Henri P, Lobbedez T. A new paradigm: home therapy for patients who start dialysis in an unplanned way. J Ren Care. 2013 Jan;39 Suppl 1:50-5. doi: 10.1111/j.1755-6686.2013.00336.x.

    PMID: 23464914BACKGROUND

  • Koch M, Kohnle M, Trapp R, Haastert B, Rump LC, Aker S. Comparable outcome of acute unplanned peritoneal dialysis and haemodialysis. Nephrol Dial Transplant. 2012 Jan;27(1):375-80. doi: 10.1093/ndt/gfr262. Epub 2011 May 28.

    PMID: 21622993BACKGROUND

  • Korevaar JC, Feith GW, Dekker FW, van Manen JG, Boeschoten EW, Bossuyt PM, Krediet RT; NECOSAD Study Group. Effect of starting with hemodialysis compared with peritoneal dialysis in patients new on dialysis treatment: a randomized controlled trial. Kidney Int. 2003 Dec;64(6):2222-8. doi: 10.1046/j.1523-1755.2003.00321.x.

    PMID: 14633146BACKGROUND

  • Vonesh EF, Snyder JJ, Foley RN, Collins AJ. Mortality studies comparing peritoneal dialysis and hemodialysis: what do they tell us? Kidney Int Suppl. 2006 Nov;(103):S3-11. doi: 10.1038/sj.ki.5001910.

    PMID: 17080109BACKGROUND

  • Chaudhary K, Sangha H, Khanna R. Peritoneal dialysis first: rationale. Clin J Am Soc Nephrol. 2011 Feb;6(2):447-56. doi: 10.2215/CJN.07920910. Epub 2010 Nov 29.

    PMID: 21115629BACKGROUND

  • Perl J, Wald R, McFarlane P, Bargman JM, Vonesh E, Na Y, Jassal SV, Moist L. Hemodialysis vascular access modifies the association between dialysis modality and survival. J Am Soc Nephrol. 2011 Jun;22(6):1113-21. doi: 10.1681/ASN.2010111155. Epub 2011 Apr 21.

    PMID: 21511830BACKGROUND

  • Heaf JG, Lokkegaard H, Madsen M. Initial survival advantage of peritoneal dialysis relative to haemodialysis. Nephrol Dial Transplant. 2002 Jan;17(1):112-7. doi: 10.1093/ndt/17.1.112.

    PMID: 11773473BACKGROUND

  • Liu FX, Ghaffari A, Dhatt H, Kumar V, Balsera C, Wallace E, Khairullah Q, Lesher B, Gao X, Henderson H, LaFleur P, Delgado EM, Alvarez MM, Hartley J, McClernon M, Walton S, Guest S. Economic evaluation of urgent-start peritoneal dialysis versus urgent-start hemodialysis in the United States. Medicine (Baltimore). 2014 Dec;93(28):e293. doi: 10.1097/MD.0000000000000293.

    PMID: 25526471RESULT

  • 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: 33320346DERIVED

Study Officials

  • Daniela ponce

    Botucatu Medical School

    STUDY DIRECTOR

Central Study Contacts

Dayana B. Dias

CONTACT

(55) 14 38116005dayanabitencourt@yahoo.com.br

Daniela Ponce

CONTACT

(55) 14 38116005dponce@fmb.unesp

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical nephrologist

Study Record Dates

First Submitted

December 15, 2015

First Posted

January 5, 2016

Study Start

November 30, 2014

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

BR(1)