RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA, BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE
AND ADDRESS (IN BLOCK LETTERS) / Dr. SANJANA A.S.
123; 6TH CROSS, IST FLOOR
BAPUJI LAYOUT, VIJAYANAGAR
BANGALORE-560 040
2. / NAME OF THE INSTITUTION / KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES HOSPITAL AND RESEARCH CENTRE, BANGALORE
3. / COURSE OF STUDY AND SUBJECT / DOCTOR OF MEDICINE
(DERMATOLOGY, STD AND VENEREOLOGY)
4. / DATE OF ADMISSION TO COURSE / 30th MAY 2009
5. / TITLE OF TOPIC / “A CLINICAL STUDY OF CUTANEOUS MANIFESTATIONS OF CHRONIC RENAL FAILURE PATIENTS ON DIALYSIS”

6. BRIEF RESUME OF THE INTENDED WORK

6.1 Need for the Study

This study is undertaken so as to understand;

a) The different clinical patterns of cutaneous lesions in chronic renal failure patients undergoing dialysis.

b)The distribution of lesions in skin and nails.

c) The associated local complications.

d) The time taken for the cutaneous lesions to resolve.

6.2 Review of Literature

Cutaneous changes associated with chronic renal failure and its management may be considered under the following headings.

A) Cutaneous manifestations of chronic renal failure

B) Cutaneous manifestations of dialysis

SKIN LESIONS ASSOCIATED WITH CHRONIC RENAL FAILURE

a) Uraemic pruritus; remains a frequent and sometimes a tormenting problem in patients with advanced or end stage renal disease. In fact, it is the most common cutaneous symptom of chronic renal failure occurring in 37-85% of patients on haemodialysis and in some patients, it may be the first sign of the renal disease.

b) Xerosis: The skin of uraemic patients is characteristically dry and scaly. The incidence of xerosis was attributed to an impairment of sweat glands with decreased sweating. In uraemic patients, plasma levels of vitamin A and its carrier protein, retinol binding protein are increased, a finding not yet reported for any other clinical condition. Xerosis has been linked with common complaint of pruritus.

c) Calcifying disorders of the skin in end stage renal disease: In Chronic renal failure, cutaneous metastatic calcification presents as benign nodular calcification (calcinosis cutis) or calciphylaxis due to defect in calcium and phosphorus metabolism.

1. Calcinosis cutis: Commonest distribution involves the periarticular sites and finger tips. Periarticular lesions are asymptomatic unless joint mobility is compromised. Finger tip lesions painful. Lesions disappear with normalization of calcium and phosphate levels below the solubility product.

2. Calciphylaxis: Calciphylaxis is devastating and life threatening condition of progressive cutaneous necrosis secondary to small vessel calcification, mortality rate estimated from 60-80%.

d)Pigmentary changes: Pico et al. found diffuse hyper pigmentation of the sun exposed areas in 22% of cases and alteration in cutaneous pigmentation in 70% of cases. In 40% of the patients, yellowish tinge was seen and skin pallor was seen in 8% of cases. Yellowish colour was attributed to the presence of lipid soluble pigments such as lipochromes and carotenoids in the epidermis and subcutaneous tissue. Diffuse hyperpigmentation of sun exposed areas has been attributed to an increase in melanin in the basal layer and superficial dermis which is due to increase in the b-MSH.

e)Nail changes: Half and half nails and red and white nails are the terms that have been used to describe nails whose proximal portion is white and distal portion is red, pink or brown occupying 20-60% of nail plate with a sharp demarcation that fades upon pressure. Half and half nails has been emphasised as a marker of uraemia. In a study consisting of 102 patients with CRF, nail changes were noted in 66% of patients.

Other changes: Reported in chronic renal failure patients include hair loss and purpura. With early and effective management of chronic renal failure, uraemic frost, Erythema Papulatum uraemicum, Uraemic roseola and Uraemic erysipeloid are rarely, if ever, seen. Atrophy of the skin have been reported.

Cutaneous manifestations associated with haemodialysis

(a) Bullous dermatoses

They have been classically subdivided into the porphyrias (e.g. Porphyria cutanea tarda and Variegata porphyria) and pseudoporphyrias (e.g. secondary to non-porphyrogenic drugs and chemicals and dialysis porphysia). They are clinically and histologically similar and are characterized by a blistering photosensitivity skin rash.

(b) Acquired perforating dermatoses

The perforating disorders of the skin are a group of diseases characterized by transepidermal elimination of material from the upper dermis. Well recognized association of chronic renal failure and is commonly seen when the underlying cause of renal failure is diabetic nephropathy and in patients undergoing haemodialysis.

Between 5-10% of patients undergoing dialysis (peritoneal or haemodialysis) develop the dermatoses and majority of these patients also have insulin dependent diabetes. An Indian study reported a prevalence of 17% and all of them were diabetics.

In an indian study,consisting of 21cases of kyrle’s disease,19 of these had renal disorders(12 patients had diabetic nephropathy,4 patients had chronic glomerulo nephritis,one patient each had renal calculi,renal tumour and benign nephrosclerosis)

(c) Gynaecomastia

This was seen in 10 (41.67%) out of 24 patients receiving maintenance haemodialysis.

(d) Psoriasis

Relationship between psoriasis and dialysis remain unclear. Psoriasis may be exacerbated, appear de novo or improve during dialysis.

(e) Local complication

Local complication at the site of insertion of cannula include extravasation, phlebitis, bacterial colonization of the cannula, septicemia may also occur in upto 8percent of cannulations.Iodine solution used as disinfectant and antiseptic may act as a contact sensitizer and cause dermatitis. An allergic dermatitis may result from the tape or bandage used to secure the dialysis cannula or tubing.

6.3 Objectives of the Study

1. To study the prevalence and clinical spectrum of cutaneous manifestations in chronic renal failure patients undergoing dialysis.

2. To compare the changes in severity of cutaneous manifestations in chronic renal failure patients on dialysis in relation to age, sex, predisposing factors.

7. MATERIALS AND METHODS

7.1 Source of Data

This study will be carried out on 100 diagnosed chronic renal failure patients who are undergoing haemodialysis at nephrology wards of KIMS Hospital and Research Centre.

7.2 Method of Collection of Data

Data will be collected using the following inclusion and exclusion criteria by personal interview and review of previous records.

B)Inclusion Criteria

Diagnosed cases of CRF patients made by the nephrologist depending on the clinical, biochemical, radiological, histopathological findings as per the requirement.

C)Exclusion Criteria

1.  Patients not willing to give written informed consent and to participate in the study.

2.  Patients with acute renal failure.

3.  Patients on peritoneal dialysis.

4.  Chronic renal failure patients who have undergone transplantation.

D)Sample size

100 subjects

E)Sample design

Purposive sampling

F)Study design

Descriptive study

G)Study Period

January 2010 to December 2010 (12 months)

H)Place of study

Department of Dermatology, KIMS Hospital and Research Centre, Bangalore

Method

Detailed history will be taken and complete clinical examination will be carried out. Clinical photographs will be taken at the beginning of the study and as and when cutaneous manifestations were encountered. Routine investigations will be carried out in all patients. Special investigations including Tzanck smear to look for multinucleated giant cells, wet mount preparations from the scraping and microscopy, skin biopsy for histopathology, when the diagnosis was in doubt, nail clipping for fungal culture, skin scraping for fungal culture, pus swab for culture and sensitivity were carried out at beginning of the study and during follow-up period whenever required. All patients will be followed up after 1 month, 6 months and 1 year intervals.

Severity of CRF graded into: Mild (serum creatinine 1.1-3.9 mg/dl); Moderate (serum creatinine 4-6.9 mg/dl); Severe (serum creatinine > 7 mg/dl).

Xerosis, pruritus, acne and hyper pigmentation graded into mild, moderate and severe depending on discomfort to the patients and clinical assessment.

Anemia graded into: Mild (Hb% 10-12 gm/dl); Moderate (Hb% 7-10 gm/dl); Severe (Hb% < 7 gm/dl).

Methodology

After obtaining clearance and approval from the institution’s ethical committee, 100 subjects who fulfill inclusion and exclusion criteria will be selected for this study. After obtaining written informed consent, the study subjects will be subjected to detailed history taking including demographic data, occupational history, drug history, personal history, family history, present and post medical history and history of previous drug reaction. Detailed physical examination to look for specific skin lesions will be done. The available case records will be scrutinized to collect valid data.

Statistical analysis involved

The data collected will be described by means of computing descriptive statistics, viz. mean, standard deviation, percentages and will be presented in the form of tables and graphs.

7.3 Does the study requires any investigation or intervention to be conducted on

patients or humans or animals ? If so, please describe briefly.

It does not require animal studies. The cost of the investigations will be borne entirely by the investigator.

1)haemoglobin

2)total count,differencial count

3)blood urea

4)serum creatinine

5)serum electrolytes;sodium,potassium,chloride,bicarbonate

6)serum calcium,serum phosphorus

7)urinr routine and microscopy

8)HIV 1 and 2

9)HBs Ag

7.4 Has ethical clearance been obtained from your institution in case of 7.3 ?

Awaited

8. REFERENCE

9. SIGNATURE OF CANDIDATE :

[Dr. SANJANA A.S.]

10. REMARKS OF THE GUIDE :

11. NAME AND DESIGNATION OF (in block letters)

11.1 Guide :

DEPARTMENT OF DERMATOLOGY

KEMPEGOWDA INSTITUTE OF

MEDICAL SCIENCES

BANGALORE

11.2 Signature :

11.3 Head of the Department : Dr. M.G. GOPAL,MD

PROFESSOR AND HEAD

DEPARTMENT OF DERMATOLOGY

KEMPEGOWDA INSTITUTE OF

MEDICAL SCIENCES

BANGALORE

11.4 Signature :

12. 12.1 Remarks of the :

Dean and Director

12.2 Signature :

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ETHICAL COMMITTEE CLEARANCE

1. / TITLE OF DISSERTATION / : / “A CLINICAL STUDY OF CUTANEOUS MANIFESTATIONS IN CRF PATIENTS ON DIALYSIS”
2. / NAME OF THE CANDIDATE / : / Dr. SANJANA A.S.
3. / SUBJECT / : /

DOCTOR OF MEDICINE

(DERMATOLOGY, STD AND VENEREOLOGY)

4. / NAME OF THE GUIDE / : / Dr.
DEPARTMENT OF DERMATOLOGY
KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES, BANGALORE
4. / APPROVED/NOT APPROVED / :

From

Dr. Sanjana A.S.

Post-Graduate in Dermatology, STD and Venereology

Department of Dermatology

Kempegowda Institute of Medical Sciences

Bangalore

To

Registrar (Evaluation)

Rajiv Gandhi University of Health Sciences

Bangalore

THROUGH PROPER CHANNEL

Respected Sir,

Subject: Submission of Synopsis titled “A Clinical Study of Cutaneous

Manifestations in CRR Patients on Dialysis”

I am hereby submitting the above titled synopsis (4 copies) as mentioned above, so kindly accept my application and do the needful.

Thanking you,

Yours faithfully,

(Dr. SANJANA A.S.)

Forwarded to Dean and Director, KIMS&RI, Bangalore for further needful action.

PROFESSOR AND HEAD

Date : Department of Dermatology, STD and Venereology

Kempegowda Institute of Medical Sciences

Hospital and Research Institute

Place: Mysore Bangalore

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