final synopsis Spectrum of biopsy finding in Rpgn patients

Spectrum of biopsy finding in Rpgn patients

1. Mahatma Gandhi Memorial Medical College, Indore
THESIS SYNOPSIS
PRINCIPAL INVESTIGATOR
Dr.Shivam Sharma
Resident Medical Officer
Department of Medicine
M.G.M. Medical College &M.Y.
Hospital, Indore
GUIDE
Dr .Shiv Shankar Sharma
Professor
M.G.M Medical College
& MYH Indore
Department of General Medicine
Spectrum of biopsy findings and outcomes in Rapidly progressive glomerulonephritis
(RPGN) patients at a tertiary care centre of central India:-a cross-sectional study
Co Guide
Dr.Pranay Bajpai
Assistant professor
M.G.M Medical college & MYH
Indore

2. •I would like to extend my sincere thanks to my guide and co guide for
the opportunity and constant supervision through out the process.
GUIDE Co Guide
Dr. Shiv Shankar Sharma Dr.Pranay Bajpai
Professor Assistant Professor
MGM medical College, M.G.M Medical college
MY hospital Indore MY Hospital,Indore

Acknowledgement

3. TITLE
“Spectrum of biopsy findings and outcomes in
Rapidly progressive glomerulonephritis (RPGN)
patients at a tertiary care centre of central
India:-a cross sectional study.”

4. INTRODUCTION
•Rapidly progressive glomerulonephritis (RPGN) manifests as a clinical
syndrome marked by rapid deterioration in renal function, often
accompanied by oliguria or anuria requiring RRT( dialysis ), and
characterized by features typical of glomerulonephritis (hematuria,
proteinuria, hypertension and oedema). RPGN can have a spectrum of
histopathological findings depending on the cause and severity.
•Understanding the diverse histo-pathological findings in RPGN patients
is crucial for defining effective long term therapeutic strategies and for
prognostication .

5. •The indian data regarding RPGN, its risk
factors and outcomes is scarce , with current
study we proposes to evaluate the
histopathological spectrum of RPGN along
with evaluation of its risk factors and
outcomes over 3 months to fill this knowledge
gap.
Rationale

6. Title “Spectrum of biopsy findings and outcomes in Rapidly
progressive glomerulonephritis (RPGN) patients at a tertiary
care centre of central India.”
AIMS & OBJECTIVES
AIM-To Study Spectrum of biopsy findings and outcomes in Rapidly
progressive glomerulonephritis (RPGN) patients at a tertiary care
centre of central India.
PRIMARY OBJECTIVE–
•To characterize the spectrum of biopsy findings in
Rapidly Progressive Glomerulonephritis patients
admitted to a tertiary care centre in Central India.
SECONDARY OBJECTIVE –
•To evaluate outcomes, including changes in renal
function and requirement for renal replacement
therapy, among RPGN patients.

7. METHODOLOGY
•Study design-Observational Study
•Study period-1 year (from the date of approval)
•Place of the study- M.G.M. MEDICAL COLLEGE AND
M.Y.HOSPITAL ,INDORE
•Sample size- All patients fulfilling the inclusion criteria during
the study period will be included with minimum patients
being 50.
1.Study Population –Patients diagnosed with Rapidly
Progressive Glomerulonephritis who underwent biopsy
admitted in M.G.M. MEDICAL COLLEGE AND M.Y.HOSPITAL
,INDORE .

8. PROCEDURE PLANNED
•Written Informed consent
•Detailed history and clinical examination as per
proforma
•Laboratory tests (CBC, Renal function test, urine
routine microscopy, and Renal biopsy (light microscopy
and immunofluorescence if required),ANCA,ANTI GBM
antibody wherever required)
•Imaging methods(USG in selected patients)

9. •Baseline data of hospitalised patients will be analysed and followed
up after 3 months.
•An ultrasound-guided percutaneous renal biopsy will be by senior
nephrologist and analysed by senior pathologist
•Depending on the type of RPGN and overall clinical status, the
patients will be treated for the disease as per standard protocol
•Patients will be followed up for a period of three months. Complete
blood counts, serum creatinine, blood urea nitrogen, urine routine
examination will be done at 15 days, 1 month and 3 month intervals.

10. INCLUSION CRITERIA
•After taking informed written consents, following
patients will be included in the study-
1.All patients of RPGN who have underwnet biopsy

11. EXCLUSION CRITERIA
Following class of patients will be excluded-
•Patients not giving consent for participation.
•Patients below 18 yrs of age
•Pregnant females and psychiatry disease patients
•Known case of chronic kidney disease.
•Significant comorbidities making biopsy unlikely(
cancer, coagulation disorder,CLD etc.)

12. Sample size formula (Cochran’s formula)
n=Z2*p*(1-p)d2
n=1.962*0.06*0.940.052
n=0.11050.0025=44.22≅50
Total sample size 50
Z = Confidence interval 95% two sided =1.96
P = The prevalence of RPGN ranges between 2 and 10% in previous
artical= average 6%=0.06
1-p = 1-0.06= 0.94
D = Absolute precision = 5%% = 0.05

13. STATISTICAL ANALYSIS PLAN
•Data will be analysed by JAMOVI
• Normal and continuous variables will he
compared using Student’s t- test,paired t-test or
ANOVA as appropriate
•Categorical variables will be compared by chi-
square test.
•For all analysis a probability value of <0.05 will be
considered statistically significant.
•Values that will retain statistical significance will be
reported with 95% confidence interval

14. OBSERVATION TABLES
Table 1: Age distribution and no. of patients with RPGN
SR.NO.AGE GROUP NO. OF PATIENTS
01 <20 years
02 21-40 years
03 41-60 years
04 >60 years
Table 2: Gender and no. of patients RPGN
MALE FEMALE
NO. OF PATIENTS

15. Etiology of rapidly progressive glomerulonephritis
RPGN No (%)
Pauci Immune
Immune complex-mediated
Anti-glomerular basement
membrane
Total
Histological Parameters
Histological Parameters
Number of glomeruli
Number of sclerosed
glomeruli
Crescents(%)
Cellular Crescents (%)
Fibrocellular crescents(%)
Tubular atrophy
Acute tubular necrosis

16. Histopathological interpretation of kidney biopsy
Pauci-immune detailed NO (%)
MPO-ANCA
PR3-ANCA
MPO-ANCA+PR3 ANCA
ANCA NEGATIVE
Immune complex-mediatedNo (%)
IgA nephropathy
Lupus nephritis
MPGN
PSGN
C3 nephropathy
Unknown
Types of immune complex-mediated diseases

17. Outcomes
VariablesComplete
Normalisati
on of RFT
(No %)
CKD not on
Dialysis (No%)
CKD on
Dialysis
(No%)
Death
(No%)
Total
Number of
patients

18. PROFORMA
IPD / OPD NO. : Date :
Name :
Age :
Sex :
Relegion:
Address :
Presenting complaints:
Significant Past History:
Significant family history:
Significant personnel history:
Treatment history:
Clinical systemic and General Examination :
Investigation
•CBC
•RFT
•URINE ROUTINE MICROSCOPY
•Renal Biopsy
•pANCA/cANCA
•AntiGBM antibody
•Complements levels (C3,C4)

19. DEPARTMENT OF MEDICINE
MGM Medical College & M. Y. Hospital, Indore
PATIENT INFORMATION DOCUMENT
The purpose of the study is “Spectrum of biopsy finding and outcome of Rapidly progressive glomerulonephritis
(RPGN) patients at a tertiary care centre of central India:-a cross-sectional study”40 patients are expected to be
included in this study.
•If you agree to participate in the study, you will be asked some questions related to your health and disease state.
•If you agree to participate in the study a renal biopsy involves removing kidney tissue for diagnosis Is done via a needle
inserted under imaging guidance. Risks include bleeding, pain, infection, injury to nearby organs, and rare complications like
blood clots or allergic reactions.
•If you agree to participate in the study,You will be given standard treatment and details of that will be noted. You will neither
be given any new or different treatment nor any extra investigations will be done on you.
•After getting discharged from the hospital, you will be contacted personally or telephonically after 3 months and certain
information will be asked from you.
•You might not be getting any additional benefits from the study but the information gathered by this may help many patients.
•The information taken from you will be kept totally confidential.
•You are totally independent to participate in this study and you can withdraw yourself from the study at any point.
•You can ask any questions related to the study from the investigators at any time.
Signature/ Thumb impression of the Subject/ Legally Acceptable
Representative:________________
Signatory’s name and contact information_____________ Date : ___________
Signature of investigator :______________
Investigator’s name and contact information: Dr. Shivam Sharma
Mobile: [phone]
Name of the Guide: Dr. Shiv Shankar Sharma
Mobile :[phone]
Name of co guide : Dr. Pranay Bajpai
Mobile:[phone]

20. रोगी जानकारी पत्र
विषय:-
।
1.इसअध्ययनमेमरीज़ोकीभागीदारीस्िेच्छिक हैऔरमरीजककसीभी समयअपनानामइसअध्ययनसेिापसलेनेकेललएस्ितंत्र
है,इसकेललए उसेककसी क़ानूनीअधिकारकीआिश्यकतानहींहै।
2.यदि आप इस अध्ययन में भाग लेने के ललए सहमत हैं, तो आपको अपने स्वास््य और रोग से संबंधित कुछ सवाल पूछे जाएंगे।
3.यदि आप अध्ययन में भाग लेने के ललए सहमत हैं तो गुिे की बायोप्सी में ननिान के ललए गुिे के ऊतकों को ननकालना शालमल है, जो इमेजजंग मागगिशगन के
तहत डाली गई सुई के माध्यम से ककया जाता है। जोखिमों में रक्तस्राव, ििग, संक्रमण, आस-पास के अंगों पर चोट और रक्त के थक्के या एलजी जैसी िुलगभ
जदटलताएँ शालमल हैं
4. आपको मानक उपचार दिया जायेगा एवं जानकाररयॉ एकत्रत्रत की जाएगी । आप पर नया या कुछ अलग इलाज नहीं ककया जाएगा और ना
ही जरूरत से ज् यािा जॉचे की जाएगी ।
5. अस् पताल से छुट्टी हो जाने के बाि आप से व् यजक्तगत या टेललफोन के माध् यम से 3महीने तक संपकग ककया जाएगा । आपसे कुछ प्रश् न
भी पूछे जाएगें ।
6.इस अध्ययन से आप को शायि ककसी भी प्रकार का अनतररक् त लाभ नहीं भी हो सकता है, लेककन एकत्रत्रत जानकारीसे कई िूसरे रोधगयों को
मिि लमल सकती है।
7. आप से ली गई जानकारी पूरी तरह से गोपनीय रिी जाएगी।
8. आप इस अध्ययन में भाग लेने के ललए पूरी तरह से स्वतंत्र हैं और आप ककसी समय पर अध्ययन से अपने आप को वापस ले सकते हैं।
9.आप ककसी भी समय जांचकतागओं से अध्ययन करने के ललए संबंधित सवाल पूछ सकते हैं।
(1) प्रततभागी का नाम ..................................
प्रततभागी का हस्ताक्षर/अंगूठे का तनशान ..................................
ददनांक ..................................
(2) मागगदशगक का नाम डॉ. लशि शंकर शमाग 9425317105
प्रोफे सर
सह मागगदशगक का नाम डॉ. प्रणय बाजपाई 9993116911

(3) अन्िेषक का नाम डॉ. लशिम् शमाग 8461954292
अन्िेषक के हस्ताक्षर ............................. ददनांक ..............
(4) गिाह का नाम ..................................
गिाह के हस्ताक्षर ............................... ददनांक..............
मध्य भारत के तृतीयक देखभाल केंद्र में भती (आरपीजीएन) रोधगयों की बायोप्सी खोज का स्पेक्ट्रम और उनके अल्पकाललक पररणाम

21. CONSENT FORM
Study title “Spectrum of biopsy finding and outcome of Rapidly progressive glomerulonephritis (RPGN) patients at a tertiary care centre of central India:-a cross-sectional study”Subject’s
Full Name _______________________________
Date of Birth/Age _______________________________
Address _________________________________________________________
_________________________________________________________
• I confirm that I have read and understood the information document dated for the above study and have had the opportunity to ask
questions. also I have been explained the nature of the study by the Investigator and had the opportunity to ask questions.
• I understand that my participation in the study is voluntary and that I am free to withdraw at any time, without giving any reason and
without my medical care or legal rights being affected.
• I understand that the Ethics and Scientific Review Committee and the regulatory authorities will not need my permission to look at my
health records both in respect of the current study and any further research that may be conducted in relation to it, even if I withdraw from the
trial. However, I understand that my Identity will not be revealed in any information released to third parties or published.
• I agree not to restrict the use of any data or results that arise from this study provided such a use is only for scientific purpose(s).
• I agree to take part in the above study.
• The information taken from you will be kept totally confidential.
Signature (or Thumb impression) of the Subject/Legally Acceptable Representative:
Signatory’s Name : __________________________Date:___________
Signature of the Investigator:________________________ Date:___________
Study Investigator’s Name : Dr. Shivam Sharma Mobile:[phone]
Name of Guide : Dr.Shiv Shankar Sharma, Mobile: [phone]
Professor
Department of Medicine
MGM Medical College & M. Y. Hospital, Indore
Name of co-Guide :Dr. Pranay Bajpai Mobile:[phone]
Assistant Professor
Department of Medicine
MGM Medical College & M. Y. Hospital, Indore
Signature of the Witness :_______________________ Date: ___________
Name of the Witness : __________________________
Received a signed copy of Participant Information Document and Consent form
Signature (or Thumb impression) of the Subject/Legally Acceptable Representative: ___________

22. ललखित व सूधचत सहमनत पत्र
ददनांक :-
रोगी का नाम :-
विषय: :- ।
मैं पुच्टि करता /करती हूूँ की मैं उपरोक्ट्त अध्ययन के ललए सूचना पत्र को पढ़ एिं समझ चुका/चुकी हूूँ और
मुझे प्रश्न पूिने का अिसर लमल चुका है
मै समझता /समझती हूूँ की इस अध्ययन मे मेरी भागीदारी स्िैच्छिक है औरमै ककसी भी समय कोई भी कारण
ददये बबना,अपने धचककत्सीय या कानूनी हकों को प्रभावित ककए बबना इस अध्ययन से बाहर तनकलने के ललए
मुक्ट्त हूूँ
मै एतद द्िारा उपरोक्ट्त अध्ययन मे सहभाधगता के ललए सहमत हूूँ
मुझे रोगी जानकारी पत्र मे उपरोक्ट्त संदलभगत अध्ययन की किया विधियों तथा मुलाकातों की संख्या के बारे मे
विस्तार पूिगक सूधचत कर ददया गया है
मुझे संभावित जोखखमो,लाभों के बारे मे स्पटि ककया गया है (रोगी जानकारी पत्र द्िारा )
मै इस अध्ययन मे भाग लेने को राजी हूूँ
रोगी की समस्त जानकारी गोपनीय रखी जाएगी।
(1) प्रततभागी का नाम ..................................
प्रततभागी का हस्ताक्षर/अंगूठे का तनशान ..................................
ददनांक ..................................
(2) मागगदशगक का नाम डॉ. लशि शंकर शमाग 9425317105
प्रोफे सर
सह मागगदशगक का नामडॉ. :. प्रणय बाजपाई 9993116911
अलसस्िेंि प्रोफे सर

(3) अन्िेषक का नाम डॉ. लशिम शमाग 8461954292
अन्िेषक के हस्ताक्षर ............................. ददनांक ..............
(4) गिाह का नाम ..................................
गिाह के हस्ताक्षर ............................... ददनांक..............
मध्य भारत के तृतीयक देखभाल केंद्र में भती (आरपीजीएन) रोधगयों की बायोप्सी खोज का स्पेक्ट्रम और
उनके अल्पकाललक गुदे और समग्र पररणाम

23. REFERENCES
1.https://www.mdpi.com/1648-9144/54/2/17
2.https://www.uptodate.com/contents/overview-of-the-classification-and-treatment-
of-rapidly-progressive-crescentic-glomerulonephritis
3.https://www.spandidos-publications.com/10.3892/etm.2019.8023

24. THANK YOU