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Dr Jeetendra Sharma
MD, IDCC, IFCC(Critical Care Medicine) PGCC(Cardiology), PGCC(Diabetes)
Consultant Critical Care Department of Critical Care Medicine MeDanta The Medicity, Gurgaon
Introduction
Severe illness and stress activates the hypothalamic pituitary adrenal axis and release of ACTH
Introduction
Preserved adrenal function - Basal serum
Method
Objective To determine the incidence of
INCLUSION CRITERIA
1. Age > 17 yrs
2. Patients fulfill criteria of sepsis ( According to American college of chest physician / society of critical care medicine consensus conference / report-1992) 3. Patients require inotropes to maintain perfusion pressure
EXCLUSION CRITERIA
Patients age 17 years Pre existing adrenal disease Adrenalectomy Known malignancy Tuberculosis (might have involved adrenal gland) Burn Hemorrhagic shock Received steroids within 3 months before admission 9. Acute MI 1. 2. 3. 4. 5. 6. 7. 8.
Method
25 patients of septic shock (community/hospital acquired) Demographic and clinical data were collected Basal corisol levels at admission (T0)were measured using VIDAS KIT An intravenous injection of 250g of ACTH (Synacthen) was given and another sample for cortisol estimation taken after 60 minutes of ACTH stimulation (T60) After Second sample Hydrocortisone 50 mg Q6H was started
Results
All results have been reported as mean and the standard
deviation
Analysis of variance (ANOVA) have been used for Tukeys method of multiple comparisons The Kruskal Wallis test and the Wilcoxon nonparametric test have been used to identify differences
Total Patients = 25
13
12
Male Female
Vital Signs
Adrenal Function Status n Temperature Heart Rate Blood Pressure
Systolic Diastolic MAP
3 8 14
Laboratory Test
AI Sodium Potassium Glucose BUN Creatinine Hemoglobin WBC Count Polymorphs Platelets
p - value
10
11 12
ESR
Total Bilirubin SGOT
55 45
1.8 2 37.7 7.4
63 60
2.6 2.9 203 260
50 46
1.3 1.1 407 1176
0.955
0.89 0.053
13
14 15 16
SGPT
Prothrombin INR APTT
38 15.3
17.4 4.1 1.4 3 3.9 10.2
105.5 189
18.8 5.2 5 10 41.4 7
162 43.2
18.5 5.2 2.8 4.6 37.4 17.7
0.190
0.964 0.743 0.452
AI 12%
3
PAF 56%
14
8
FHA 32%
60
51.84
50 40 30 20
11.57 17.64
10 0 AI
3.26
FHA
PAF
Adrenal Insufficiency
3 (100%)
Functional Hypoadrenalism
8
14
2 (25%)
7 (50%)
6 (75%)
7 (50%)
Conclusion
In present study the incidence of adrenal
Conclusion
Sepsis can cause occult adrenal insufficiency in the presence of normal or even elevated serum cortisol Overall mortality was 48 % in our study group and, statistically there was no difference in mortality among adrenal insufficiency, functional
hypoadrenalism and preserved adrenal function group. However, the mortality was 100% in the adrenal insufficiency group.
References
SCCM/ESICM/ACCP/ATS/SIS, International sepsis definition conference. Critical care medicine 31;4:2003
Rivers et al: Early Goal directed therapy in the treatment of severe sepsis and septic shock, NEJM 2001,345;19:1368-1377
Annane D, et al. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA 2002;288:862-71 Charles L. et al: Hydrocortisone Therapy for Patients with Septic Shock-CORTICUS Study Group. N EJ M 2008;358:111-24. Dellinger RP. Cardiovascular management of septic shock. Crit Care Med 2003; 31:946-55.
Research
Quest for knowledge through systematic and scientific way on a specific topic, aimed at discovery and interpretation of new knowledge
RCT
Case Series
Post marketing survey
CME
Expert Opinion
Study/Trial
1. Who wrote the paper?
2. Do they or the institution have a proven
academic record?
3. Is the paper interesting and relevant?
Title
Study/Trial - Introduction
1. Did the study introduction address the
relevant points? 2. Was the study original? 3. Were the aims clearly stated?
Hypothesis
.our hypothesis was that there is a significant interaction of vasopressin and corticosteroid treatment in septic shock
Crit Care Med 2009; 37:811 818
Study/Trial - Methods
Was an appropriate group of subjects studies?
Study Design
Post hoc substudy of a multicenter randomized blinded controlled trial
Post hoc analysis of VAST
Cohort Study
Large population of patients who have a specific condition or receive a particular treatment over time Compared with another group that has not been affected Observational Not as reliable as RCTs, since the two groups may differ in ways other than in the variable under study.
Patients who already have a specific condition are compared with people who do not. They often rely on medical records and patient recall Statistical relationship does not mean than one factor necessarily caused the other
RCT
2 groups, one treatment group and one control group. Patients are randomly assigned to all groups. Assigning patients at random reduces the risk of bias Helps creation of groups similar in their risk of the events Balances the groups for prognostic factors Increases the probability that differences between the groups is due to the treatment
Suggested best type of Study RCT > cohort > case control > case series prospective, blind comparison to a gold standard RCT > cohort > case control > case series cohort study > case control > case series RCT > cohort study > case control > case series prospective, blind comparison to gold standard
Cost
economic analysis
Study/Trial - Methods
Drug treatment - randomised controlled trial Prognosis - cohort study Causation - case - control study Were the study groups comparable?
Study/Trial - Methods
Were the groups treated equally other than for the experimental intervention? Were the outcome measures stated and relevant?
treatment given?
Errors
Frame error
Sampling error
Chance error
Response error
Drawback
Study/Trial - Methods
Were all patients entered into the study properly
accounted for?
Is there any missing data? Were side effects and adverse outcome documented? Was the duration and completeness of follow up appropriate?
Study/Trial - Statistics
1. Were the statistical methods described?
2. Does the tests chosen reflect the type of data 3. Parametric versus parametric tests
Errors - Outcome
Type I () Rejecting the null hypothesis when it is true Type II () Accepting the null hypothesis when it is false Type III () Correctly rejecting null hypothesis for wrong reason
Errors
Example
Out of 10 smokers 9 have Ca lung
Out of 10 smokers 5 have Ca lung Out of 10 smokers 1 has Ca lung
Avoid error; Power Avoid error; P value
Power
It is the probability that the test reject a false null hypothesis (will not make type II error) As power increases, chance of type II error decreases Power = 1-
CORTICUS TRIAL
Results
mortality at 28 days
Hydrocortisone group
86 of 251 (34.3%)
Placebo
78/248 (31.5%)
P = 0.51
Study Population
Study Population
Nonparametric
Mann-Whitney U-test Wilcoxon matched paired test Kruskall-Wallis test 2 test
Example
Girls Ht V/s Boys Ht Wt of infant before/after feed B sugar1,2or3 h after meal Acceptance in to medical school more likely if born in UK HbA1C related to TG level in DM
2 test For any association b/w 2 categorical variables ; NOT indicate what the association
Results
1. How large was the treatment effect?
2. How precise was the estimate of the treatment effect?