Outcome of Peritoneal Dialysis peritonitis with switch from glucose based dialysate to icodextrin.
- Conditions
- renal failure on peritoneal dialysis
- Registration Number
- CTRI/2012/07/002842
- Brief Summary
Introduction: In peritoneal dialysis patients, peritonitis is the one common infective complication associated with significant morbidity and mortality (1) and foremost reason for drop out and change of modality to hemodialysis. Many different strategies including use of dialysis solutions with low glucose degradation products have been tried but with no further difference in peritonitis rates (2). Furthermore, over years, no significant improvement in the outcome of peritoneal dialysis-associated peritonitis is noticed (3). Any improvement in peritonitis outcome is likely to improve the overall management of peritoneal dialysis patients.
One of the most important aspects of management of sepsis in a diabetic patient is blood glucose control. Even in non-diabetic subjects, it has been shown that abnormal glucose levels can increase the morbidity and LOS (length of stay) in patients with Pneumonia (4). Studies have shown direct correlation with prevalence of infections and mean plasma glucose levels (5). The reasons for increased prevalence of infections and morbidity in diabetics have been studied. It has been demonstrated that there is significant diminution in intracellular bactericidal activity of leucocytes and serum opsonic activity with Staph Aureus and E. coli in patients with poorly controlled diabetes (5). Leucocytes’ phagocytic ability is also compromised in diabetics as shown in mouse models leading to impaired bacterial clearance (6). Similarly, it can be hypothesized that during an episode of peritonitis, the very high concentration of glucose in peritoneum, in glucose based dialysate, may lead to poor outcome of PD peritonitis. Non- glucose based dialysate like icodextrin may have an advantage in the outcome of peritoneal dialysis related peritonitis. Icodextrin already has been shown to be advantageous in ultrafiltration failure (7), in diabetics (8), and in high transporters (8). Icodextrin two exchanges a day has also been studied in different case studies earlier (9. 10). However, outcome of peritonitis with switch to icodextrin has not been studied to the best of my knowledge and hence, it is worth looking at the outcome of peritonitis with switch from glucose to icodextrin based dialysate.
Aim: To look at the outcome of peritonitis with glucose based dialysate versus non-glucose based dialysate (icodextrin) during an episode of peritonitis.
Study design: Multicenter Randomized Open label study
Materials and Methods: A total of 40 stable adult peritoneal dialysis patients will be included in the study. They will be randomized by a central computer generated random number and divided into two groups – group A will be shifted to 2 exchanges of icodextrin per day within 24 hours of diagnosis and confirmation of peritonitis; and group B will continue with the conventional glucose based dialysis. Patients with history of peritonitis within last 1 month will be excluded. Patients with hepatitis B, C or HIV will also be excluded from the study. Patients on immunosuppressant drugs will also be excluded. The initial management of peritonitis will be as per the ISPD 2010 guidelines, which will be followed in all the centers. Subsequent management will depend on the sensitivity pattern of the culture of the PD fluid. The primary outcome measure will be recovery from peritonitis, which will be compared between the two groups. The secondary outcome will be comparison, between the groups, of days to normalize the fluid cell count, catheter removal, and death from peritonitis.
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References:
1. Nessim SJ. Prevention of peritoneal dialysis-related infections. Semin Nephrol 2011; 31 (2): 199-212.
2. Diaz-Buxo JA, Himmele R. Strategies to universally improve peritonitis rates, including use of dialysis solutions with low glucose degradation products. Adv Perit Dial 2010; 26: 37-40.
3. Brown MC, Simpson K, Kerssens JJ, Mactier RA; the Scottish renal registry. Peritoneal dialysis-associated peritonitis rates and outcomes in National cohort are not improving in the post-millenium (2000-2007). Perit Dial Int 2011; 31 (6): 639-50.
4. Godar DA, Kumar DR, Schmelzer KM, Talsness SR, Liang H, Schmelzer JR, Mazza JJ, Yale SH. The impact of serum glucose on clinical outcomes in patients hospitalized with community-acquired Pneumonia. WMJ 2011; 110: 14-20.
5. Rayfield EJ, Ault MJ, Keusch GT, Brothers MJ, Nechemias C, Smith H. Infection and Diabetes: the case for glucose control. Am J Med 1982; 72 (3): 439-50.
6. Pettersson US, Christoffersson G, Massena S, Ahl D, Jansson L, Henriksnas J, Phillipson M. Increased recruitment but impaired function of leucocytes during inflammation in mouse models of Type 1 and type 2 diabetes. Plos ONE 2011; 6 (7): e22480
7. Mistry CD, Gokal R, Peers E. A randomized multicenter clinical trial comparing isoosmolar icodextrin with hyperosmolar glucose solutions in CAPD. MIDAS study group. Multicenter investigation of icodextrin in Ambulatory Peritoneal Dialysis. Kidney Int 1994; 46 (2): 496-503.
8. Paniagua R, Ventura MD, Avila-Diaz M, Cisneros A, Vicente-Martinez M, Furlong MD, Garcia-Gonzalez Z, Villanueva D, Orihuela O, Prado-Uribe MD, Alcantara G, Amato D. Icodextrin improves metabolic and fluid management in high and high-average transport diabetic patients. Perit Dial Int 2009; 29 (4): 422-32.
9. Sav T, Oymak O, Inanc MT, Dogan A, Tokgoz B, Utas C. Effects of twice daily icodextrin administration on blood pressure and left ventricular massin patients on continuous peritoneal dialysis patients. Perit Dial Int 2009; 29 (4): 443-9.
10. Dousdampanis P, Trigka K, Chu M, Khan S, Venturoli D, Oreopoulos DG, Bargman JM. Two icodextrin exchanges per day in peritoneal dialysis patients with ultrafiltration failure: one center’s experience and review of the literature. Int Urol Nephrol 2011; 43(1): 203-9.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
- Signed informed consent.
- Men or women above 18 years of age.
- Subject with history of peritonitis within last 1 month.
- Subject with history of hepatitis B, C or HIV.
- Subject on immunosuppressant drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •The primary outcome measure will be recovery from peritonitis, which will be compared between the two groups. 2-4 weeks
- Secondary Outcome Measures
Name Time Method •The secondary outcome will be comparison, between the groups, of days to normalize the fluid cell count, catheter removal, and death from peritonitis. 2-4 weeks
Trial Locations
- Locations (5)
Aditya Birla Memorial Hospital
🇮🇳Pune, MAHARASHTRA, India
AIIMS
🇮🇳Central, DELHI, India
Apollo Victor hospital
🇮🇳Goa, GOA, India
Jehangir hopsital
🇮🇳Pune, MAHARASHTRA, India
Sanjay Gandhi Post graduate Institute
🇮🇳Lucknow, UTTAR PRADESH, India
Aditya Birla Memorial Hospital🇮🇳Pune, MAHARASHTRA, IndiaTarun JelokaPrincipal investigator02030717689tjeloka@yahoo.com