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CTRI Number  CTRI/2012/07/002842 [Registered on: 30/07/2012] Trial Registered Prospectively
Last Modified On: 30/07/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Outcome of Peritoneal Dialysis peritonitis with switch from glucose based dialysate to icodextrin. 
Scientific Title of Study   A randomized, open label, multi-Centre study to evaluate the outcome of peritonitis with switch From glucose based dialysate to icodextrin during an episode of peritonitis.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CTMR/ABMH/Nephro/11004  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tarun Jeloka 
Designation  Sr Consultant Nephrologist 
Affiliation  Aditya Birla Memorial Hospital 
Address  Aditya Birla Memorial Hospital Pune
Thergaon Pune
Pune
MAHARASHTRA
411033
India 
Phone  30717703  
Fax    
Email  tjeloka@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Tarun Jeloka 
Designation  Sr Consultant Nephrologist 
Affiliation  Aditya Birla Memorial Hospital 
Address  Aditya Birla Memorial Hospital Pune
Thergaon Pune
Pune
MAHARASHTRA
411033
India 
Phone  30717703  
Fax    
Email  tjeloka@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Swati Niture 
Designation  Research Cordinator 
Affiliation  Aditya Birla Memorial Hospital 
Address  Aditya Birla Memorial Hospital
Thergaon Pune
Pune
MAHARASHTRA
411033
India 
Phone  30717703  
Fax    
Email  swtn21@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  None 
Address  Nil 
Type of Sponsor  Other [Self by patient] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Tarun Jeloka  Aditya Birla Memorial Hospital  Department of Nephrology, Room No L2, Thergaon
Pune
MAHARASHTRA 
02030717689

tjeloka@yahoo.com 
Dr Sandeep Mahajan  AIIMS  Department of Nephrology, New Delhi 29
Central
DELHI 
9810546844

mahajansn@yahoo.com 
Dr Shital Lengade  Apollo Victor hospital  Department of Nephrology, Malbath, Margaon
South Goa
GOA 
9890914373

shitallengade@indiatimes.com 
Dr S M Ambike  Jehangir hopsital  Department of Nephrology opp Pune station
Pune
MAHARASHTRA 
9822049385

drsmambike@yahoo.co.in 
Dr Narayan Prasad  Sanjay Gandhi Post graduate Institute  Department of Nephrology Rai Barieley road
Lucknow
UTTAR PRADESH 
9415403140

narayan.nephro@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Aditya Birla Memorial Hospital  Approved 
AIIMS  Submittted/Under Review 
Apollo Victor Hospital  Submittted/Under Review 
Jehangir Hospital  Submittted/Under Review 
SGPGI  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  renal failure on peritoneal dialysis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Glucose based dialysate  During peritonitis, this arm will continue on the same treatment i.e. glucose based dialysate for the study period / duration of treatment for peritonitis .  
Intervention  Icodextrin  "During peritonitis, Ico group will be shifted from glucose based dialysate to 2 exchange of icodextrin of 12 hour duration for the study period / duration of treatment for peritonitis." 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Signed informed consent.
2. Men or women above 18 years of age.
 
 
ExclusionCriteria 
Details  1. Subject with history of peritonitis within last 1 month.
2. Subject with history of hepatitis B, C or HIV.
3. Subject on immunosuppressant drugs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• The primary outcome measure will be recovery from peritonitis, which will be compared between the two groups.  2-4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
• 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 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/08/2012 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.

 

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.

 
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