Dialysate Temperature in Peritoneal Dialysis

NCT04302649 | Completed Phase 4

• 1 other identifier: 165/2018/SPER/AOUMO
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Patients on continuous ambulatory peritoneal dialysis (PD) are encouraged to warm dialysate to 37°C before peritoneal infusion; main international PD guidelines do not provide specific recommendation, and patients generally warm dialysate batches partially or do not warm them at all. Warming of dialysate is a time-consuming procedure, not free from potential risks (i.e. degradation of glucose), and should be justified by a clear clinical benefit. The investigators designed a single blind randomized controlled trial where PD patients were randomized to receive a peritoneal equilibration test either with dialysate at a controlled temperature of 37°C (intervention group) or with dialysate warmed with conventional methods (control group). Primary end-point was a higher peritoneal creatinine clearance in patients in the intervention group.

Conditions

Peritoneal Dialysis Complication

Keywords

peritoneal dialysis; dialysate temperature; peritoneal creatinine clearance

Outcome Measures

Primary Outcomes (1)

• peritoneal creatinine clearance

  Peritoneal clearance of creatinine was calculated with the following formula: Cx = \[Dx\] x dialysate volume / \[Px\] / 240 where Cx represents clearance of creatinine expressed in ml/min, \[Dx\] represents the concentration of creatinine in dialysate at the end of the exchange (4 hours) expressed in mg/dl, dialysate volume represents the total volume drained at the end of the exchange (4 hours), \[Px\] represents the concentration of creatinine in plasma after 2 hours from the beginning of the exchange expressed in mg/dl and 240 represents minutes contained in the 4 hours of the exchange.

  4 hours - Peritoneal equilibration test

Secondary Outcomes (2)

• peritoneal urea clearance

  4 hours - Peritoneal equilibration test

• creatinine and urea mass transfer area coefficient

  4 hours - Peritoneal equilibration test

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients received Peritoneal Equilibration Test (PET). In the intervention group, dialysate was warmed in a specific microwave oven calibrated to 37°C and infusion temperature was confirmed to be 37°C before infusion

Drug: peritoneal dialysate at 37°C temperature

Control group

NO INTERVENTION

Patients received Peritoneal Equilibration Test (PET). In the control group, current practice was used (batch warming with a pad calibrated to 37°C) and dialysate temperature was measured just before infusion.

Interventions

peritoneal dialysate at 37°C temperature DRUG

during a PET test, patients received peritoneal dialysate warmed at 37°C before infusion

Intervention group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years
• ability to give informed consent
• peritoneal dialysis (PD) treatment
• PD vintage of more than 3 months
• absence of signs of active acute systemic or localized infections at least four weeks apart from the trial

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

Study Sites (1)

Azienda Ospedaliera Universitaria di Modena

Modena, Emilia-Romagna, 41124, Italy

Location

Related Publications (13)

• Fernandez-Reyes MJ, Bajo MA, Del Peso G, Ossorio M, Diaz R, Carretero B, Selgas R. The influence of initial peritoneal transport characteristics, inflammation, and high glucose exposure on prognosis for peritoneal membrane function. Perit Dial Int. 2012 Nov-Dec;32(6):636-44. doi: 10.3747/pdi.2011.00137. Epub 2012 Apr 2.

  PMID: 22473036 BACKGROUND

• Bargman JM, Krediet RT, Lo WK, Selgas R, del Peso G, Auxiliadora Bajo M, Mujais S. What are the problems with using the peritoneal membrane for long-term dialysis? Semin Dial. 2008 Jan-Feb;21(1):11-23. doi: 10.1111/j.1525-139X.2007.00385_1.x. No abstract available.

  PMID: 18251949 BACKGROUND

• Aroeira LS, Aguilera A, Sanchez-Tomero JA, Bajo MA, del Peso G, Jimenez-Heffernan JA, Selgas R, Lopez-Cabrera M. Epithelial to mesenchymal transition and peritoneal membrane failure in peritoneal dialysis patients: pathologic significance and potential therapeutic interventions. J Am Soc Nephrol. 2007 Jul;18(7):2004-13. doi: 10.1681/ASN.2006111292. Epub 2007 Jun 13.

  PMID: 17568021 BACKGROUND

• Dombros N, Dratwa M, Feriani M, Gokal R, Heimburger O, Krediet R, Plum J, Rodrigues A, Selgas R, Struijk D, Verger C; EBPG Expert Group on Peritoneal Dialysis. European best practice guidelines for peritoneal dialysis. 7 Adequacy of peritoneal dialysis. Nephrol Dial Transplant. 2005 Dec;20 Suppl 9:ix24-ix27. doi: 10.1093/ndt/gfi1121. No abstract available.

  PMID: 16263748 BACKGROUND

• Welten AG, Schalkwijk CG, ter Wee PM, Meijer S, van den Born J, Beelen RJ. Single exposure of mesothelial cells to glucose degradation products (GDPs) yields early advanced glycation end-products (AGEs) and a proinflammatory response. Perit Dial Int. 2003 May-Jun;23(3):213-21.

  PMID: 12938820 BACKGROUND

• Fontana F, Ballestri M, Makomi C, Morandi R, Cappelli G. Hemorheologic alterations in peritoneal dialysis. Clin Hemorheol Microcirc. 2017;65(2):175-183. doi: 10.3233/CH-16152.

  PMID: 27340762 BACKGROUND

• Gross M, McDonald HP Jr. Effect of dialysate temperature and flow rate on peritoneal clearance. JAMA. 1967 Oct 23;202(4):363-5. No abstract available.

  PMID: 6072310 BACKGROUND

• Indraprasit S, Namwongprom A, Sooksriwongse C, Buri PS. Effect of dialysate temperature on peritoneal clearances. Nephron. 1983;34(1):45-7. doi: 10.1159/000182977.

  PMID: 6855994 BACKGROUND

• Saghaei M. Random allocation software for parallel group randomized trials. BMC Med Res Methodol. 2004 Nov 9;4:26. doi: 10.1186/1471-2288-4-26.

  PMID: 15535880 BACKGROUND

• Teixido-Planas J. Peritoneal function and adequacy calculations: current programs versus PD Adequest 2.0. Perit Dial Int. 2002 May-Jun;22(3):386-93.

  PMID: 12227398 BACKGROUND

• Figueiredo AE, Goodlad C, Clemenger M, Haddoub SS, McGrory J, Pryde K, Tonkins E, Hisole N, Brown EA. Evaluation of physical symptoms in patients on peritoneal dialysis. Int J Nephrol. 2012;2012:305424. doi: 10.1155/2012/305424. Epub 2012 Sep 25.

  PMID: 23050149 BACKGROUND

• Twardowski ZJ. Clinical value of standardized equilibration tests in CAPD patients. Blood Purif. 1989;7(2-3):95-108. doi: 10.1159/000169582.

  PMID: 2663040 BACKGROUND

• Fontana F, Torelli C, Giovanella S, Ligabue G, Alfano G, Gerritsen K, Selgas R, Cappelli G. Influence of dialysate temperature on creatinine peritoneal clearance in peritoneal dialysis patients: a randomized trial. BMC Nephrol. 2020 Oct 27;21(1):448. doi: 10.1186/s12882-020-02113-z.

  PMID: 33109094 DERIVED

Related Links

• Agency BR. Warming Peritoneal Dialysis Solutions.

Study Officials

• Gianni Cappelli, Professor

  University of Modena and Reggio Emilia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 10, 2020
• Study Start: October 1, 2018
• Primary Completion: December 24, 2018
• Study Completion: December 31, 2018
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)