Dialysate Temperature in Peritoneal Dialysis

NCT ID: NCT04302649

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2018-12-31

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.

Detailed Description

Peritoneal dialysis (PD) currently represents the main choice for home renal replacement treatment for patients with end stage renal disease. One of the limitations of PD technique is represented by the difficulty in achieving target dialytic clearances and PD adequacy for some patients, especially with increasing PD vintage. A potentially relevant issue in PD clearances is the effect of dialysate temperature on depuration. Indeed, it is common for clinicians to advise patients in Continuous Ambulatory Peritoneal Dialysis (CAPD) to warm the dialysate before infusion into the peritoneal cavity, with different methods (microwave oven, warming cabin, warming pad). Nevertheless, main international PD guidelines do not provide specific recommendations on this topic. Only guidelines from the British Columbia Renal Agency (Canada) dedicate a specific chapter to the temperature of dialysate, recommending its warming to 37°C before peritoneal infusion, mainly in order to avoid an "uncomfortable lowering of body temperature". On the other hand, warming of PD batches could lead to hot spots formation inside the batch, especially with microwaves, and to degradation of glucose leading to the formation of toxic glucose degradation products (GDPs). Also, notable differences in room temperature exist according to geographical latitude and year season, and there are no clear and detailed reports in the literature regarding intolerable effects of the infusion of dialysate at room temperature. It must be acknowledged that it is common practice for patients to warm dialysate batches only partially or not to warm them at all. Moreover, warming pads that are most commonly used by CAPD patients do not effectively warm the dialysate up to 37°C. In the Peritoneal Dialysis Unit at Azienda Ospedaliero-Universitaria di Modena, it was recently observed that average dialysate temperature at infusion was 31.1°C, even if the pad was calibrated to 37°C [unpublished data]. With respect to the effects on toxins clearances through the peritoneal membrane, a higher dialysate temperature could theoretically favor vasodilation of peritoneal membrane microcirculation, potentially increasing the passage of substances. Severe microcirculatory dysfunction has been reported in PD patients and any intervention designed to ameliorate microcirculatory flow at peritoneal level could be beneficial. Surprisingly, reports regarding the effects of dialysate temperature on peritoneal clearances in PD in humans are surprisingly scarce. In 1967 Gross et al reported an increase in the exchange of substances between peritoneal fluid and blood upon warming of the PD fluid to 37°C (compared to 20°C) in a patient treated with intermittent peritoneal dialysis; the increase in urea clearance with the 37°C solution was 35% on average. In contrast, Indraprasit et al did not encounter differences in peritoneal creatinine clearance utilizing dialysate at room temperature (27-31°C) and warmed at 37°C in a group of 18 patients in PD. Confirmation of the effects of dialysate temperature on peritoneal clearances would be of great interest in order to maximize the depurative potential of PD and to justify patients' effort to warm the batches.

In order to determine the real effects of dialysate temperature on peritoneal clearances and transport characteristics, abdominal discomfort and vital signs, the investigators designed a randomized controlled trial comparing two strategies of peritoneal dialysate warming.

Study design and participants PD patients, both in CAPD and automated PD, in regular follow-up at the Nephrology Unit of the University Hospital of Modena, were randomized to receive a single dialysis exchange, either with dialysate at a controlled temperature of 37°C (intervention group) or with dialysate at warmed with conventional methods at uncontrolled temperature (control group). Randomization was generated through the use of the Random Allocation software11.

Primary end-point of our study was peritoneal creatinine clearance. Secondary end-points were: peritoneal urea clearance, creatinine and urea mass transfer area coefficient (MTAC), abdominal discomfort, blood pressure and body temperature.

A power analysis was performed while designing the study using the few data available in the literature; setting the alpha-error level at 0.05 for a 2-tailed t-test with a statistical power of 95% (beta-error 0.05) the estimated sample needed was 14 patients (7 per group).

Conditions

Peritoneal Dialysis Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

peritoneal dialysate at 37°C temperature

Intervention Type: DRUG

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

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

peritoneal dialysate at 37°C temperature

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria di Modena

OTHER

Sponsor Role: lead

Responsible Party

Gianni Cappelli

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gianni Cappelli, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Modena and Reggio Emilia

Locations

Azienda Ospedaliera Universitaria di Modena

Modena, Emilia-Romagna, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 22473036 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18251949 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17568021 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16263748 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12938820 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27340762 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6072310 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6855994 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15535880 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12227398 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23050149 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 2663040 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33109094 (View on PubMed)

Related Links

http://www.bcrenalagency.ca/resource-gallery/Documents/Warming%20Peritoneal%20Dialysis%20Solutions.pdf

Agency BR. Warming Peritoneal Dialysis Solutions.

Other Identifiers

165/2018/SPER/AOUMO

Identifier Type: -

Identifier Source: org_study_id