Sourab - Rajiv Gandhi University of Health Sciences



SYNOPSIS

Rajiv Gandhi University of Health Sciences, Karnataka,

Bangalore.

“Prediction of clinical outcome in hepatic encephalopathy in chronic liver disease by analyzing serum ammonia and clinical hepatic encephalopathy staging scale (CHESS).”

Name of the candidate  : Dr. Vijayamahantesh N

     Nidagundi

Guide   :         Dr. Venkatesha B M

Course and Subject : M.D (General Medicine)

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Department of General Medicine,

Father Muller Medical College,

Kankanady, Mangalore – 575002.

JULY – 2013

Rajiv Gandhi University of Health Sciences, Karnataka,

Bangalore

Annexure II

|1. |Name of the Candidate |DR VIJAYAMAHANTESH N NIDAGUNDI |

| |And |P G Resident |

| |Address |Father Muller Medical College |

| | |Kankanady |

|2. |Name of the Institution |Father Muller Medical College |

| | |Kankanady |

| | |Mangalore |

|3. |Course of study and subject |M D General Medicine |

|4. |Date of admission to course | 27th MAY 2013 |

|5. |Title of the Topic- |

| |Prediction of clinical outcome in hepatic encephalopathy in chronic liver disease by analyzing serum ammonia and clinical hepatic |

| |encephalopathy staging scale (CHESS). |

|6. |Brief resume of the work |

| |6.1 Need for the study |

| |Hepatic encephalopathy (HE) is a potentially reversible disorder with a wide spectrum of neuropsychiatric abnormalities in patients|

| |with liver dysfunction. It manifests as a neuropsychiatric syndrome which may result in impairment of sleep-wake cycle, cognition, |

| |memory, consciousness, personality changes and motor-sensory abnormalities. Hepatic encephalopathy develops in 30% to 45% of |

| |patients with liver cirrhosis and its subclinical form (minimal hepatic encephalopathy) can affect up to 60% of patients with liver|

| |disease. HE is an independent predictor of mortality rate1. The exact toxin involved in pathogenesis remains controversial but |

| |ammonia is thought to be an important marker. An elevated ammonia level is an indication to institute therapy. Most of the |

| |precipitants of HE cause rise in serum ammonia levels. Early identification and correction of precipitating factors remains the |

| |cornerstone in the management of hepatic encephalopathy. Studies have been done to correlate plasma levels and severity of HE. |

| |However no study has been done to correlate serum ammonia levels with outcome. The aim of this study is to look for the predictors |

| |of outcome in hepatic encephalopathy by analyzing serum ammonia and CHESS at admission. |

| | |

| |6.2 Review of Literature: |

| |World Congresses of Gastroenterology defines Hepatic Encephalopathy (HE) as a clinical condition characterised by presence of |

| |cerebral dysfunction in patient with liver disease. Diagnosis of HE is based on careful neuropsychiatric evaluation. Clinically HE |

| |is classified based on the underlying hepatic abnormality into three types; Type A (associated with acute liver disease), Type B |

| |(associated with portosystemic bypass and no intrinsic hepatocellular disease), and Type C (associated with chronic liver disease |

| |and portal hypertension) Type C is further classified in to Episodic HE, Persistent HE and Covert HE.2 |

| |A study by Udayakumar et al showed that high bilirubin values predict poor outcome but neither advanced grade of West –Haven |

| |criteria nor rapidity of onset correlate with outcome.3 But another study by Rashid et al on 316 cirrhotics showed that West Haven |

| |stage IV of hepatic encephalopathy and esophageal variceal bleed are associated with prolonged hospital stay and higher mortality.4|

| |HE is associated with many measurable chemical mediators like elevated levels of ammonia, gamma aminobutyric acid (GABA), |

| |decreased levels of glutamine, serotonin, histamine and melatonin. A study done by Ong et al on serum ammonia and severity of HE in|

| |121 patients concluded that ammonia levels correlates with severity of hepatic encephalopathy and venous sampling is adequate for |

| |ammonia measurement.5 A study on predictive value of arterial ammonia for outcome in acute liver failure on 80 patients in AIIMS |

| |Delhi, found out that high arterial ammonia levels at admission is associated with poor outcome and increased seizure frequency.6 |

| | |

| |Various scoring systems like West Haven Criteria, CHESS, and Hepatic Encephalopathy Scoring Algorithm (HESA) have been developed to|

| |grade the severity of hepatic encephalopathy. Ortiz el al in their research on development of clinical hepatic encephalopathy |

| |staging scale and have concluded that the evaluation of multiple neurological manifestations is not necessary to classify hepatic |

| |encephalopathy and it can be assessed by the patient’s orientation, alertness, ability to respond to commands and to talk. CHESS |

| |score is based on observation of 9 clinical manifestation of HE, each manifestation is given a score of one. Severity of HE is |

| |scored from 0 (low) to 9 (high). It is a simple scaling system which can be administered by health care providers without special |

| |training.7 |

| |Objective of the study: |

| |To predict the outcome in the form of mortality and duration of stay in hospital in patients with HE by analyzing serum ammonia and|

| |CHESS scoring system at admission. |

| |To correlate between serum ammonia levels at admission and CHESS score at admission. |

| | |

| |Materials and Methods |

| |7.1 Source of data: |

| |        The data will be collected from patients admitted to Father Muller Medical College Hospital(FMMCH) from 1st October 2013 to|

| |1st March 2015. |

| |7.2. STUDY DESIGN |

| |Descriptive - cross sectional study |

| |7.3. Method of collection of data: |

| |The study will include a minimum of 50 patients admitted to FMMCH diagnosed as hepatic encephalopathy on the basis of history, |

| |physical findings and mental status changes. These patients will be evaluated within 24 hrs of admission by a detailed history |

| |regarding age, sex , personal history, past history along with general physical examination, examination of signs of liver cell |

| |failure and systemic examination. Mental status changes will be analyzed by psychometric testing such as drawing a star, spiral or |

| |square. |

| |Chronic liver disease diagnosis will be based on past records or present abdominal ultrasonography findings. Blood tests like |

| |PT/INR, venous serum ammonia, complete blood count, renal function test, blood culture and urine analysis will be done at |

| |admission. Severity will be determined by CHESS score within 24 hours. Treatment for hepatic encephalopathy is directed towards |

| |reducing the amount of ammonia that enters the systemic circulation from the gastrointestinal tract using lactulose, rifaximin, |

| |probiotics, and bowel wash. Patient’s ability to draw a star and disappearance of asterixis will be considered as recovery from |

| |hepatic encephalopathy. Outcome will be correlated with the serum ammonia levels at admission and CHESS. Serum ammonia levels will |

| |be correlated with CHESS score. |

| | |

| |Outcome will be defined in terms of |

| |Mortality. |

| |Recovery from hepatic encephalopathy and discharge from hospital- length of hospital stay. |

| |Inclusion Criteria : |

| |Patient presenting with altered sensorium with a history of pre-existing or newly diagnosed chronic liver disease. |

| |Exclusion Criteria. |

| |Altered sensorium with local deficits due to – trauma, intracranial bleed, space occupying lesions, and stroke will be excluded |

| |clinically. |

| |Psychiatric disease causing altered sensorium will be excluded with the help of previous records. |

| |Metabolic derangements without history of chronic liver disease. |

| |Alcohol consumption within 1 week. |

| |Type A and Type B hepatic encephalopathy. |

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| |Data Analysis: |

| |         Data will be analyzed by frequency, percentage, mean, standard deviation, Karl Pearson correlation coefficient, Chi square|

| |test and Receiver Operating Characteristic (ROC) curve analysis . |

| |7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? |

| |Yes |

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

| |Yes |

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| |LIST OF REFERENCES: |

| |Eroglu Y, Byrne WJ. Hepatic encephalopathy. Emerg Med Clin North Am. 2009; 27:401-14. |

| |Ferenci P, Lockwood A, Mullen K, Tarter R, Weissenborn K, Blei AT. Hepatic encephalopathy definition, nomenclature, diagnosis, and |

| |quantification: final report of the working party at the 11th World Congresses of Gastroenterology,Vienna, 1998. Hepatology. |

| |2002;35:716-21. |

| |Udayakumar N, Subramaniam K, Umashankar L, Verghese J, Jayanthi V. Predictors of mortality in hepatic encephalopathy in acute and |

| |chronic liver disease: a preliminary observation. J Clin Gastroenterol. 2007;41:922-6. |

| |Rashid M, Khan J, Khan M A, Rahman A. Predictors of outcome in patients with type C hepatic encephalopathy. Gom J of Med Sci. 2012|

| |; 10:80-3. |

| |Ong JP, Aggarwal A, Krieger D, Easley KA, Karafa MT, Van Lente F, Arroliga AC, Mullen KD. Correlation between ammonia levels and |

| |the severity of hepatic encephalopathy. Am J Med. 2003 Feb 15;114:188-93. |

| |Bhatia V, Singh R, Acharya SK. Predictive value of arterial ammonia for complications and outcome in acute liver failure. Gut. |

| |2006;55:98-104. |

| |Onyekwere CA, Ogbera AO, Hameed L. Chronic liver disease and hepatic encephalopathy: clinical profile and outcomes. Niger J Clin |

| |Pract. 2011;14:181-5. |

|9. |Signature of candidate | |

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|10. |Remarks of the guide | |

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|11. |11.1Name and Designation of |DR. VENKATESHA B M, MD |

| |Guide |PROFESSOR AND HEAD OF DEPARTMENT |

| | |DEPARTMENT OF MEDICINE |

| | |FATHER MULLER MEDICAL COLLEGE |

| | |KANKANADY |

| | |MANGALORE |

| | | |

| | | |

| |11.2 Signature | |

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| |11.3 Head of Department |DR. VENKATESHA B M , MD |

| | |PROFESSOR AND HOD OF MEDICINE |

| | |DEPARTMENT OF GENERAL MEDICINE |

| | |FR. MULLER MEDICAL COLLEGE |

| | |KANKANADY, MANGALORE – 575002 |

| | | |

| |11.4 Signature | |

|12 |12.1 Remarks of chairman & principal | |

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| |12.2 Signature | |

GUARDIAN CONSENT FORM

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|I Mr/Mrs _____________________________ of Mr/Mrs |

|bearing FMMCH IP No _________ have been explained in detail by the attending physician/investigator in my own language about the |

|study purpose. It has been clarified to me that clinical details will be kept confidential and will be used only for academic |

|purpose like in medical education, publication works and for improvement in patient care. |

|To my best satisfaction, the attending physician/investigator has informed me about the procedure and cost involved in the study. I |

|completely agree with this and comply with all medical directions given to me. On my own decision and self interest, I give my |

|consent as a guardian of patient to take part in the study, “Prediction of clinical outcome in hepatic encephalopathy in chronic |

|liver disease by analyzing serum ammonia and clinical hepatic encephalopathy staging scale (CHESS)”. |

| |

|Signature of the investigator Signature of the guardian |

|Date: |

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|Signature of the witness and name |

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