RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1) NAME OF CANDIDATE: DR. AUREEN RUBY D’CUNHA
2) NAME OF INSTITUTION: ST. JOHN’S MEDICAL COLLEGE
KORAMANGALA, BANGALORE
560034
3) COURSE OF STUDY AND SUBJECT: M.S. GENERAL SURGERY
4) DATE OF ADMISSION TO COURSE: 23RD MARCH 2011
5) TITLE OF THE TOPIC:
THE EFFECT OF ORGAN DYSFUNCTION ON THE MORBIDITY AND MORTALITY IN PATIENTS WITH SURGICAL PROBLEMS
6) BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY
The commonest cause of death in surgical patients is sepsis. Sepsis being a common problem, may ultimately evolve into shock and MODS resulting in early morbidity and mortality. Once a patient enters SIRS (systemic inflammatory response syndrome) the risk of evolving into full blown MODS is high if timely intervention does not take place. Whether halting this sequence of events is possible and to what extent, is varied, and how many organ systems failure ultimately lead to mortality of the patient is still a query.
The morbidity of life threatening infection is reflected in the development of multiple organ dysfunction syndrome (MODS), so reliable and valid tools to quantify MODS is an important pre requisite for the evaluation and treatment of patients with infection. In general terms, outcome measures in clinical trials are being used to answer one of the two questions namely
Does the intervention work (is a biological effect evident?)
Does the intervention help? (Is there evidence of clinical benefit?)
I would like to investigate the effect and degree of organ dysfunction on the morbidity and mortality of people with surgical problems using a scoring system such as SOFA scoring. Such information would help in the following:
Ø The possibility of recovery/residual illness/death following the involvement of multiple organ systems.
Ø To counsel the family members regarding the prognosis of the patient and the option of continuing or discontinuing treatment if the prognosis/outcome is grave.
Ø Possibly when and how to intervene to prevent progression to full blown MODS.
The standard definitions will be considered on SIRS [4,5,6]:
SIRS (SYSTEMIC INFLAMMATORY RESPONSE SYNDROME):Two or more of the following:
▪ Temperature (core) >38°C or <36°C
▪ Heart rate >90 beats/min.
▪ Respiratory rate of >20 breaths/min for patients spontaneously ventilating or a PaCo2 <32 mm Hg.
▪ WBC count >12,000 cells/mm3 or <4000 cells/mm3 or >10% immature (band) cells in the peripheral blood smear.
SEPSIS: SIRS with microbial etiology.
SEVERE SEPSIS/SEPSIS SYNDROME: Sepsis with one or more signs of organ dysfunction.
SEPTIC SHOCK: Sepsis with hypotension for atleast one hour despite adequate fluid resuscitation OR need for vasopressors to maintain SBP 90 or MAP 70.
REFRACTORY SEPTIC SHOCK: septic shock lasting >1 hour and not responding to vasopressors.
MODS: Dysfunction of more than one organ requiring intervention to maintain hemostasis.
REVIEW OF LITERATURE
Various studies done have evaluated similar issues including:
A non interventional study in the Surgical intensive care unit (ICU) of a tertiary-level teaching hospital on all patients (n equals 692) admitted for more than 24 hrs between May 1988 and March 1990. [1]. Variables from these studies were evaluated for construct and content validity to identify optimal descriptors of organ dysfunction. Clinical and laboratory data were collected daily to evaluate the performance of these variables individually and in aggregate as an organ dysfunction score. Seven systems defined the multiple organ dysfunction syndrome in more than half of the 30 published reports reviewed. Descriptors meeting criteria for construct and content validity could be identified for five of these seven systems: a) the respiratory system (PO2 /FIO2 ratio); b) the renal system (serum creatinine concentration); c) the hepatic system (serum bilirubin concentration); d) the hematologic system (platelet count); and e) the central nervous system (Glasgow Coma Scale). For CVS a new variable was formulated- pressure adjusted heart rate (product of the heart rate and the ratio of central venous pressure to mean arterial pressure). Each parameter was graded from 0 to 4 0 being the least and the maximum.
Using these parameters, the criterion validity (ICU mortality rate) was calculated using a scale from 0 to 4 for each variable, 0 being normal and representing ICU mortality rate of less than 5%, whereas a value of 4 represented marked functional derangement and an ICU mortality rate of 50%. These intervals were then tested on the second half of the data set (the validation set). Maximal scores for each variable were summed to yield a Multiple Organ Dysfunction Score (maximum of 24). This score correlated in a graded fashion with the ICU mortality rate, both when applied on the first day of ICU admission as a prognostic indicator and when calculated over the ICU stay as an outcome measure. For the latter, ICU mortality was approximate 25% at 9 to 12 points, 50% at 13 to 16 points, 75% at 17 to 20 points, and 100% at levels of more than 20 points. The incremental increase in scores over the course of the ICU stay (calculated as the difference between maximal scores and those scores obtained on the first day [i.e., the Delta Multiple Organ Dysfunction Score]) also demonstrated a strong correlation with the ICU mortality rate. In a logistic regression model, this incremental increase in scores accounted for more of the explanatory power than admission severity indices.
Conclusions: This multiple organ dysfunction score, correlates well with the ultimate risk of ICU and hospital mortality.The variable, Delta Multiple Organ Dysfunction Score, reflects organ dysfunction developing during the ICU stay, which therefore is potentially amenable to therapeutic manipulation.
A study done in May 1995 which was a non interventional prospective multicentre study done to evaluate the use of the Sequential Organ Failure Assessment (SOFA) score in assessing the incidence and severity of organ dysfunction in critically ill patients.The setting was Forty intensive care units (ICUs) in 16 countries and included patients admitted to the ICU in May 1995 (n = 1,449), excluding patients who underwent uncomplicated elective surgery with an ICU length of stay <48 hrs.
Measurements and Main Results: The main outcome measures included incidence of dysfunction/failure of different organs and the relationship of this dysfunction with outcome. In this cohort of patients, the median length of ICU stay was 5 days, and the ICU mortality rate was 22%. Multiple organ dysfunction and high SOFA scores for any individual organ were associated with increased mortality. The presence of infection on admission (28.7% of patients) was associated with higher SOFA scores for each organ. The evaluation of a subgroup of 544 patients who stayed in the ICU for at least 1 wk showed that survivors and nonsurvivors followed a different course. This subgroup had greater respiratory, cardiovascular, and neurologic scores than the other patients. In this subgroup, the total SOFA score increased in 44% of the nonsurvivors but in only 20% of the survivors (p < .001). Conversely, the total SOFA score decreased in 33% of the survivors compared with 21% of the nonsurvivors (p < .001).
Conclusions: The SOFA score is a simple, but effective method to describe organ dysfunction/failure in critically ill patients. Regular, repeated scoring enables patient condition and disease development to be monitored and better understood. The SOFA score may enable comparison between patients that would benefit clinical trials.[2]
Another study done in Toronto, Canada, done to evaluate Organ dysfunction as an outcome measure in clinical trials [8]. They described a model, based on previously published MOD score (a measure of biological effect) that permitted evaluation of both biological effect and clinical benefit, using readily available and commonly measured variables. Such a measure is potentially useful in evaluating the effects of new treatments, and in understanding the interactions of the biological process of MODS and its familiar clinical signs [3]
The SOFA (Sequential assessment of organ dysfunction) system was created in a consensus meeting of the European Society of Intensive Care Medicine in 1994 and further revised in 1996. The SOFA is a six-organ dysfunction/failure score measuring multiple organ failure daily. Each organ is graded from 0 (normal) to 4 (the most abnormal), providing a daily score of 0 to 24 points. Calculation of SOFA score during the first few days of ICU admission is a good indicator of prognosis. Both the mean and highest SOFA scores are particularly useful predictors of outcome. Independent of the initial score, an increase in SOFA score during the first 48 hours in the ICU predicts a mortality rate of at least 50%.
The SOFA score is a scoring system to determine the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems.
The score tables below only describe points-giving conditions. In cases where the physiological parameters do not match any row, zero points are given. In cases where the physiological parameters match more than one row, the row with most points is picked.
·Respiratory System
PaO2/FiO2 (mmHg) / SOFA score< 400 / 1
< 300 / 2
< 200 and mechanically ventilated / 3
< 100 and mechanically ventilated / 4
Nervous System
Glasgow coma scale / SOFA score13 – 14 / 1
10 – 12 / 2
6 – 9 / 3
< 6 / 4
Cardio Vascular System
Mean Arterial Pressure OR administration of vasopressors required / SOFA scoreMAP < 70 mm/Hg / 1
dop <= 5 or dob (any dose) / 2
dop > 5 OR epi <= 0.1 OR nor <= 0.1 / 3
dop > 15 OR epi > 0.1 OR nor > 0.1 / 4
(vasopressor drug doses are in mcg/kg/min)
Liver
Bilirubin (mg/dl) / SOFA score1.2 – 1.9 / 1
2.0 – 5.9 / 2
6.0 – 11.9 / 3
> 12.0 / 4
Coagulation Profile
Platelets×103/mcl / SOFA score< 150 / 1
< 100 / 2
< 50 / 3
< 20 / 4
Renal System
Creatinine (mg/dl) (or urine output) / SOFA score1.2 – 1.9 / 1
2.0 – 3.4 / 2
3.5 – 4.9 (or < 500 ml/d) / 3
> 5.0 (or < 200 ml/d) / 4
Other scoring systems [7]
· Glasgow Coma Scale (also named GCS) is designed to provide the status for the central nervous system. It is often used as part of other scoring systems.
· MPM - Mortality Prediction Model
o model to assess risk of death at ICU admission
o has prediction models for assessment at admittance, 24h, 48h and 72h after
· MODS Multiple Organ Dysfunction Score
o with similar objectives as SOFA Score
· LODS Logistic Organ Dysfunction System developed for evaluation at admittance and not as a monitoring tool.
6.3 OBJECTIVES OF THE STUDY
PRIMARY OBJECTIVE
TO ASSES THE EFFECT OF ORGAN DYSFUNCTION ON THE MORBIDITY AND MORTALITY IN PATIENTS WITH SURGICAL SEPSIS.
SECONDARY OBJECTIVE
v TO COUNSEL THE PATIENTS RELATIVES REGARDING PERCENTAGE OF MORTALITY AT A GIVEN POINT OF TIME
v TO ASSESS DAILY PROGRESS AND PREDICT MORBIDITY/MORTALITY BASED ON RESPONSE TO THE TREATMENT
v TO FIND OUT WHEN MORTALTIY BECOMES 100%
7.0) MATERIALS & METHODS
Surgical Patients admitted in SJMCH (between the period October 2011-October 2013) who are in SIRS/sepsis/shock/MODS will be included in this study.
The minimum number of cases being kept is at n=30
All basic investigations included in SOFA scoring will be analysed including PT/INR and serum albumin, on a daily basis for the patients included in the study.
7.1)SOURCE OF DATA
Data will be collected from the inpatients in the surgical ICU and will be included in the study.
7.2) METHOD OF COLLECTION OF DATA
Initially the following will be collected: History & clinical examination
Blood investigations
Biopsies & cultures
The parameters involved in the SOFA scoring will be followed up on a daily basis for one week.
I will also be considering additional 2 parameters including PT/INR (Prothrombin time) and Serum Albumin and comparing the results between the above and the original SOFA scoring.
A proforma will be made including provision to maintain the patients day to day progress and to calculate scores.
7.3) INCLUSION & EXCLUSION CRITERIA
All the following patients will be included in the study:
ü All adult patients with surgical problems (operative or non operative) in the /ICU at St. John’s Medical College Hospital
ü All patients showing features of SIRS/sepsis/shock/MODS including unconscious/comatose patients.
All of the following patients will be excluded from the study:
ü Children (below the age of 16 years)
ü Patients who are not on ventilator
ü Patients who expire within 2 hours of admission
ü Non surgical patients
STUDY DESIGN
The study will be a prospective non interventional study.
8.0 REFERENCES
1) Multiple Organ Dysfunction Score: A reliable descriptor of a complex clinical outcome.
Marshall, John C. MD FRCSC; Cook, Deborah J. MD MSc, FRCPC; Christou, Nicolas V. MD PhD, FCCM; Bernard, Gordon R. MD; Sprung, Charles L. MD JD, FCCM; Sibbald, William J. MD FCCM
(Crit Care Med 1995; 23:1638-1652 )
2) Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: Results of a multicenter, prospective study
Vincent, Jean-Louis MD, PhD, FCCM; de Mendonca, Arnaldo MD; Cantraine, Francis MD; Moreno, Rui MD; Takala, Jukka MD, PhD; Suter, Peter M. MD, FCCM; Sprung, Charles L. MD, JD, FCCM; Colardyn, Francis MD; Blecher, Serge MD.
(Critical Care Medicine November 1998 - Volume 26 - Issue 11 - pp 1793-1800
Feature Articles)
3) Organ dysfunction as an outcome measure in clinical trials.
PMID: 11705032 [PubMed - indexed for MEDLINE] .Eur J Surg Suppl. 1999;(584):62-7.
4) BAILEY & LOVE’S: SHORT PRACTICE OF SURGERY, 25TH EDITION
5) SABISTON TEXTBOOK OF SURGERY 18TH EDITIION
6) SCHWARTZ PRINCIPLES OF SURGERY 8TH EDITION
7) Canadian Journal of Anesthesia / Journal canadien d'anesthésie
Volume 52, Number 3, 224-230, DOI: 10.2007/BF03016054
9.0) SIGNATURE OF THE CANDIDATE:
10.0) REMARKS OF THE GUIDE:
11.0) NAME & DESIGNATION (IN BLOCK LETTERS):
11.1) GUIDE:
11.2) SIGNATURE:
11.3) CO GUIDE:
11.4) SIGNATURE:
11.5) HEAD OF DEPARTMENT:
11.6) SIGNATURE: