Download level of serum creatine kinase and magnesium as prognostic

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BANGALORE,KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR
DISSERTATION
Dr.DEBASISH BARIK
1.
Name of the candidate and address
POST GRADUATE IN GENERAL
MEDICINE
BANGALORE MEDICAL
COLLEGE AND RESEARCH
INSTITUTE,BANGALORE-560002
2
Name of the institution
BANGALORE MEDICAL
COLLEGE AND RESEARCH
INSTITUTE,BANGALORE-560002
3
Course of study and subject
M.D. IN GENERAL MEDICINE
4
Date of admission to the course
17TH AUGUST,2013
5
Title of the topic
“LEVEL OF SERUM CREATINE
KINASE AND MAGNESIUM AS
PROGNOSTIC INDICATORS IN
ACUTE ORGANOPHOSPHORUS
POISONING.”
6.Brief resume of intended work:
6.1 Need for study:
Organophosphorus(OP)insecticides are arguably one of the commonest causes of
morbidity and mortality due to poisoning worldwide especially in developing
countries like India.The morbidity and mortality depends on the time lag between the
exposure and the onset of management.With increase use of compounds for
agricultural and industrial purposes and due to easy access and low cost,they are
becoming a major source of health hazard.So it is cardinal to recognize the entire
spectrum of symptoms.Identification,risk stratification,early diagnosis and prompt
treatment of OP poisoning victims are equally vital.These compounds act by
inhibiting the enzyme acetylcholinesterase which result in accumulation of
acetylcholine in nervous tissue and effector organs, principal site being the peripheral
nervous system.[1,2]
Patients with acute Organophosphorus(OP) poisoning are usually monitored by using
serum acetylcholinesterase level which are expected to fall.It is not specific and does
not correlate with the severity of poisoning and cannot be used as a prognostic
indicator.[3]Estimation of creatine Kinase is easy and levels are increased both in acute
phase as well as in intermediate syndrome due to muscle fibre necrosis.[2]
Magnesium levels are usually reduced in Organophosphorus poisoning due to
gastrointestinal loss,vomiting,diarrohia ,prolonged gastric aspiration.
Many manifestation of hypomagnesemia overlap with features of Organophosphorus
poisoning.So it may be a contributory factor in severity and outcome.[4]
Considering all these factors this study is being undertaken.
6.2.Review of Literature:
A study conducted at Kolkata medical College by Kuntal Bhattacharya et al found the
correlation between initial increase in serum creatine kinase level and increased risk
of complications like respiratory paralysis,arrythmia and increased atropine
requirement in patients with acute organophosphorus poisoning.[2]
A Study conducted by abdolkarim pajoumond at poison control centre,loghmanhakim hospital,school of medicine,saheed behesti university of medical
sciences,tehran, Iran concluded that giving MgSO4 in a dose of 4g per day alongwith
conventional therapy reduced the stay in the hospital and rate of mortality.[5]
A reveiw article published by paudyal BP,department of medicine,patan
hospital,Lalitpur has mentioned regarding Magnesium sulphate as the newer mode of
therapy in acute organophosphorus poisoning.Also other modes like fresh frozen
plasma,anti oxidants,organophosphorus hydrolases,sodium bicarbonate and
gacyclidine(NMDA receptor antagonist) are coming up as latest therapeutic
advances.[6]
A study conducted by M John et al at department of medicine in CMC vellore showed
correlation between the development of muscle injury producing a raised CK level
and intermediate syndrome[7].
A study conducted by Singh G,Avasthi G,Khurana D, Whig J, Mahajan R at the
department of medicine ,Dayanand Medical college ,Ludhiana,India showed the
administration of MgSO4.7H2O at 4 g I.V resulted in a decrease in compound muscle
action potential amplitude,loss of repetitive response and conversion of the decrement
increment response at higher rate repetitive nerve stimulation to an increment
response[8].
6.3.Objective of study:
1.To assess and categorise the severity of organophosphorus poisoning cases
clinically ,on admission by Peradeniya Organophosphorus Poisoning scale.
2.To estimate the serum levels of creatine kinase and magnesium in acute
Organophosphorus poisoning and to correlate the same with clinical severity scoring
at admission and serially till discharge.
7.MATERIALS AND METHODS
7.1.Source of data:
This consists of patients admitted in the department of medicine of Victoria Hospital
and Bowring and Lady Curzon Hospital attached to Bangalore Medical College and
Research Institute
7.2.Method of collection of data:
A.Study design: cross sectional prospective study design.
B.Study period:November 2013 to October 2015
C.Place of study:
The study is planned to be conducted in Victoria hospital and Bowring and Lady
Curzon hospital.
D.Sample size:150 patients.
E.Inclusion criteria:All cases of acute organophosphorus poisoning admitted to our
hospital within 12 hours of consumption of the poison irrespective of age and sex
whose caregivers are willing to give written informed consent.
F.Exclusion criteria:
1.Other pesticide poisoning.
2. Mixed poisoning.
3. Consumption of poison with alcohol .
4. Known medical illness like chronic liver disease, myopathy, malignancy, renal
failure, autoimmune disorder, coronary artery disease . .
5. Patients on chronic drugs like statins, steroids.
G. Methodology:
After obtaining clearance and approval from the institutional ethics committee and
written informed consent of the caregiver,patients admitted to the emergency with
organophosphorus compound consumption will be selected after fulfillment of
inclusion and exclusion criteria and enrolled in the study(Annexure I).
The eligible patients will be initially subjected to peradeniya Organophosphorus
poisoning scale and will be categorised according to severity.(Annexure IV)
All routine investigations like CBP,RFT,SE,LFT,ECG,RBS,URINE(R/E),will be
performed.
Apart from these investigations the other investigations to be done:
1.Serum Cholinesterase level
2.Serum Creatine kinase level
3.Serum magnesium level.
The serum creatine kinase and magnesium level will be correlated with the initial
peradeniya clinical scoring and subsequently on day 2,3 and on discharge.(Annexure
V)
H.Statistical analysis:
The data obtained will be analysed using
1.Chi square test
2.Analysis of variance
3.Unpaired Student t test
7.3.Does the study require any investigation or interventions to be conducted in
patients or animals?if so describe briefly.
Animals: NO
Patients:patient’s caregiver’s written informed consent will be taken.
The following investigations are needed for the study
Complete blood count
Liver function test
Renal function test
Serum electrolytes
Random blood sugar
Urine Routine
ECG
Serum cholinesterase
Serum creatine kinase
Serum magnesium
7.4.Has the ethical clearance been obtained from ethics committee of your
institution in case of 7.3?
“YES”,ethical clearance has been obtained from the ethics committee of our
institution.
8.LIST OF REFERENCES:
1.Ernest Hodgson.Organophosphorus insecticides:Ernest Hodgson,Department of
Environmental and Biochemical Toxicology,North Carolina State University,editor.A
text book of modern toxicology.3rd ed.USA:Wiley-interscience;2004.p.58-60.
2. Kuntal Bhattacharya,Sibaji Phaujdar ,Rathindranath Sarkar and Omar S.Mullick
.Serum creatine phosphokinase: A probable marker of severity in organophosphorus
poisoning.Toxicol Int 2011 jul-dec;18(2):117-123.
3.Semir Nouira,Fekri Abroug,Souhil Elatrous,Ratik Boujdaria,Slah
Bouchoucha.Prognostic value of serum cholinesterase in organophosphate
poisoning.Chest 1994;106(6):1811-1814
4.CS Limaye,VA Londhey,MY Nadkar,NE Borges.Hypomagnesemia in critically ill
medical patients.Journal of the Associations of Physicians of India 2011;59:19-22.
5.Abdolkarim Pajoumand,Shahin Shadina,Ali Rezaie,Mehboobeh Abdi,Mohammad
Abdollahi.Benifits of magnesium sulphate in the management of acute human
poisoning by organophosphorus insecticide.Hum Exp Toxicol.2004 dec;23(12):565569.
6.Paudayal BP .Organophosphorus Poisoning.J Nepal Med Assoc.2008;47(172):251258.
7.M John,A Oommen,A Zachariah .Muscle injury in organophosphorus poisoning and
its role in the development of intermediate syndrome .Neurotoxicology.2003
jan;24(1):43-53
8.Singh G,Avasthi G,Khurana D,Whig J,Mahaian R.Neurophysiological Monitoring
of Pharmacological manipulation in acute organophosphorus poisoning .the effect of
pralidoxime,magnesium sulphate and pancuronium.Electroencephalog.Clin
Neurophysiol.1998 Aug;107(2):140-148.
9.MgSO4 Treatment against Sarin Poisoning :Dissociation between overt convulsion
and recorded cortical seizure activity.Archives Of Toxicology.February
2013;87(2):347-360.
10.Balali Mood M,Saber H.Recent advances in the treatment of organophosphorus
poisoning.Iranian Journal of Medical science 2012;37(2):74-91.
11.Dursun Aygun,Ali Kemal Erenler ,Ayedin Deniz Karatas,Ahmet
Baydin.Intermediate syndrome following Acute Organophosphate
poisoning:Correlation with initial Serum levels of Muscle Enzymes.Basic Clin
Pharmacol Toxicol 2007;100(3):201-204.
9.
Signature of the candidate
10.
Remarks of the Guide
Acute organophosphorus compound poisoning
is very common among patients admitted to
casualty in our hospitals.Methods to
diagnose,monitor and prognosticate are non
specific.There is a need to develope the
parameters other than clinical in these patients
for the better outcome.Creatine kinase and
magnesium levels appear to be good options
in this aspect.
11.
Name and Designation of
DR. NAGARAJA B.S, MD
11.1 Guide
Professor,Department of General Medicine
BMC&RI,Bangalore
11.2 Signature
DR.PRABHAKAR.B, MD
11.3 Head of the Department
11.6 Signature
12.
12.1 Remarks of Chairman and
principal
12.2 signature
Professor&HOD,Department of General
Medicine,BMC&RI,Bangalore.
ANNEXURE III
STUDY PROFORMA
DATE:
I.P. NO.
PATIENT IDENTIFICATION NO.
I.PATIENT INFORMATION:
NAME
AGE
SEX
I.P. NO.
ADDRESS
PHONE No.
OCCUPATION
II.POISONING
COMPOUND
AMOUNT
TIME OF
CONSUMPTION
III.SYMPTOMS:
VOMITING
LOOSE STOOLS
SALIVATION/LACRIMATION/SWEATING
DYSPNOEA
BLURRING OF VISION
SEIZURES
LOSS OF CONSCIOUSNESS
IV.PAST HISTORY:
DIABETES MELLITUS
HYPERTENSION
BRONCHIAL ASTHMA/COPD
TUBERCULOSIS
V.PERSONAL HISTORY:
SMOKING
ALCOHOLISM
VI.SYSTEMIC EXAMINATION:
CVS
RS
ABDOMEN
CNS
VII.INVESTIGATIONS:
CBP
LFT
RFT
SE
RBS
URINE(R/E)
ECG
AchE(DAY 1)
ANNEXURE IV
PERADENIYA ORGANOPHOSPHORUS SCALE
PARAMETERS
0
1
2
PUPIL SIZE
≥2 mm
<2mm
PINPOINT
RESPIRATORY
RATE
<20/min
≥20/min
HEART RATE
>60/min
41-60/min
FASCICULATION
None
Conscious
and
LEVEL OF
CONSCIOUSNESS rationale
SEIZURE
Absent
GRADE
Mild(0-3)
Present
Generalised/continuous
Impaired response to
verbal commands
Present
Moderate(4-7)
≥20/min with
central
cyanosis
<40/min
Both
generalised
and continuous
No response
to verbal
commands
Severe(8-11)
SCORE
ANNEXURE V
SERIAL ESTIMATION OF SERUM CREATINE KINASE AND MAGNESIUM
DAY 1
DAY 2
DAY 3
ON
DISCHARGE
SERUM CK
SERUM
MAGNESIUM
CLINICAL
SCORING
ATROPINE
REQUIREMENT
COMPLICATIONS
IF ANY
DURATION OF HOSPITAL STAY
-
ANNEXURE I
PROFORMA FOR WRITTEN INFORMED CONSENT
Date:
Place:
I,Mr/MS/Mrs
, son/daughter/wife of Mr.
,aged
about
years, have been explained in a language understood by me about the
study entitled “LEVEL OF SERUM CREATINE KINASE AND MAGNESIUM
AS PROGNOSTIC INDICATORS IN ACUTE ORGANOPHOSPHORUS
POISONING”.at the department of general medicine of Victoria hospital and
Bowring and Lady Curzon hospital,Bangalore.
I have been explained about the procedures and investigations that will be done during
this study. I have no objections in sharing my patient’s medical information and
details in case records with the investigators of this study.I have been informed that I
will not be sharing any incentives.Personal identity will not be revealed and data may
be used for publication/dissertation purpose.
I understand that my patient’s participation in this study is entirely voluntary and I
willfully give consent regarding participation of my patient in this study for the
specified duration.
Signature of the caregiver
Relation with the patient
Signature of the doctor