Dialysate Temperature in Peritoneal Dialysis

Peritoneal Dialysis Complication Clinical Trial

— TPD  

Official title:

Influence of Dialysate Temperature on Peritoneal Creatinine Clearance in Patients in Peritoneal Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302649
• Other study ID #: 165/2018/SPER/AOUMO
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2020
• Source: Azienda Ospedaliero-Universitaria di Modena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2018
• Est. primary completion date: December 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Dialysis Complication

Intervention

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

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria di Modena	Modena	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Modena

Country where clinical trial is conducted

Italy, 

References & Publications (12)

Aroeira LS, Aguilera A, Sánchez-Tomero JA, Bajo MA, del Peso G, Jiménez-Heffernan JA, Selgas R, López-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. Epub 2007 Jun 13. Review. — View Citation

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. Review. — View Citation

Dombros N, Dratwa M, Feriani M, Gokal R, Heimbürger 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. — View Citation

Fernández-Reyes MJ, Bajo MA, Del Peso G, Ossorio M, Díaz 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. — View Citation

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. — View Citation

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. — View Citation

Gross M, McDonald HP Jr. Effect of dialysate temperature and flow rate on peritoneal clearance. JAMA. 1967 Oct 23;202(4):363-5. — View Citation

Indraprasit S, Namwongprom A, Sooksriwongse C, Buri PS. Effect of dialysate temperature on peritoneal clearances. Nephron. 1983;34(1):45-7. — View Citation

Saghaei M. Random allocation software for parallel group randomized trials. BMC Med Res Methodol. 2004 Nov 9;4:26. — View Citation

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

Twardowski ZJ. Clinical value of standardized equilibration tests in CAPD patients. Blood Purif. 1989;7(2-3):95-108. Review. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	peritoneal urea clearance	Peritoneal clearance of urea was calculated with the following formula: Cx = [Dx] x dialysate volume / [Px] / 240 where Cx represents clearance of urea expressed in ml/min, [Dx] represents the concentration of urea 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 urea 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	creatinine and urea mass transfer area coefficient	Mass transfer area coefficients (MTAC) for creatinine and urea were calculated with the RenalSoft software (converted from the PD Adequest software) from Baxter Healthcare, Deerfield, IL, U.S.A. Correction for plasmatic water concentration was not added, since the main purpose was to compare MTACs from the intervention and control group and not to obtain absolute data.	4 hours - Peritoneal equilibration test

External Links

•   Agency BR. Warming Peritoneal Dialysis Solutions.