Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363149
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-09
Brief Title:
Disseminated Intravascular Coagulation DIC Score and Organ Dysfunction in Septic Shock Patients
Sponsor:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Organization:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Study Overview
Official Title:
Effect of Disseminated Intravascular Coagulation DIC Score Changes on Organ Dysfunction in Septic Shock Patients
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Septic shock is common complication in patients with critical illnesses with higher incidence in low and medium income countries like ours Disseminated intravascular coagulation DIC is also common in patients presenting to intensive care units Further DIC is common coexisting condition seen in many patients presenting with sepsis and septic shock
Both DIC and septic shock individually are associated with very high mortality and morbidity and coexistence of both increase risk manifold Organ dysfunction is a complication of both septic shock and DIC individually and in presence of coexistence risk further multiply DIC scoring of every patient at risk as in patients presenting with septic shock help us to predict about patients having more chances to convert to overt DIC
Understanding effects of DIC on organ dysfunction in septic shock patients can help to prognosticate and guide towards early intervention Also there is paucity of literature on effect of DIC score changes on organ dysfunction in patients with septic shock
Both DIC and septic shock individually are associated with very high mortality and morbidity and coexistence of both increase risk manifold Organ dysfunction is a complication of both septic shock and DIC individually and in presence of coexistence risk further multiply DIC scoring of every patient at risk as in patients presenting with septic shock help us to predict about patients having more chances to convert to overt DIC
Understanding effects of DIC on organ dysfunction in septic shock patients can help to prognosticate and guide towards early intervention Also there is paucity of literature on effect of DIC score changes on organ dysfunction in patients with septic shock
Detailed Description:
Background and rationale for the study Septic shock patients and DIC commonly coexist and progression to overt DIC is serial process Sepsis and septic shock condition is a prevalent condition as studied by Stephen et al especially in low medium income countries with incidence of 315 million per year Divatia JV et al found incidence of severe sepsis and septic shock 283 in study covering different ICUs in India Rhee C et al found incidence of severe sepsis and septic shock as high as 528 MarxG et al observed incidence of septic shock in German ICUs to be 126 whereas Mulatu HA et al found it to be 265 in African ICUs
Also septic shock has very high mortality rates In India Divatia JV et al observed that mortality in septic shock patients was 534 and Chatterjee et al observed it to be 628 Mortality rate according to different geographical locations have variations but still consistently high 228 mortality in Greece ICUs 79 in Turkish ICUs observed by Baykara et al in Japan 27 in Taiwan 438 in China 519
Disseminated intravascular coagulation DIC is prevalent entity in sepsisseptic shock patients as observed in different studies Ko BS et al observed prevalence to be 176 Dhainut JF et al found it to be 289 Saito et al in Japan to be 29 and J Kienast et al in Germany observed it to be 407
DIC itself has high mortality 291 407 50 and as high as 56 Mortality rates further increases when DIC co exists with severe sepsis as seen 676 by Ogura H et al 446 vs 553 without and with DIC respectively seen by Hayakawa et al 117 vs 541 without and with DIC respectively seen by Solanki D et al
Septic shock patients are at high risk of develop multiple organ dysfunction MODS In fact both DIC score and organ dysfunction were found increased in patients with septic shock as compared to patients without septic shock so the resultant higher mortality and MODS Studies also found mortality risk further increases in septic shock patients with the presence of DIC
Methodology Study design This prospective observational study will be conducted at the Department of Critical Care Medicine in collaboration with the Department of Haematology SGPGIMS Lucknow after the approval from the Institutional Ethics Committee IEC Study protocol During the study period all adult ICU participants with the diagnosis of septic shock will be considered as per inclusion and exclusion criteria DIC scores and SOFA scores will be calculated and followed-up for the 14 days
Definition and scores Septic shock is defined as a subset of sepsis in which particularly profound circulatory cellular and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone Participants with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure of 65 mmHg or greater and serum lactate level greater than 2mmolL in the absence of hypovolemia Sepsis -3 recommendations DIC score for overt and non-overt DIC will be used as per International Society on Thrombosis and Haemostasis ISTH Sample collection for DIC score calculation Blood samples will be collected as below Baseline sampling At inclusion Second sampling At 72 hours 12 hours Third sampling After 72 hours 12 hours of second sampling Data collections Demographic and relevant clinical characteristics of included participants will be collected on structured case report form
Sample size and statistical analysis Based on the study conducted by the H Ogura et al 2014 SOFA score was during the day 1 10738 to day 4 8950 Change in score Cohen d effect size 0398 At minimum two-sided 95 confidence and 80 power of the study minimum estimated sample size for the study is 52 Finally minimum 60 participants to be enrolled in the study Sample size was estimated using software Gpower version 3197 Descriptive statistics of the continuous variables will be presented as mean SD Median IQR whereas categorical variables in Frequency To compare the observations between baseline to follow-up data quantitative variable with the outcomes two-way repeated measures ANOVA will be used One way Analysis of covariance to be used to compare the post observations into outcomes after the adjusting the baseline measurements Change in the SOFA score with change in the DIC score to be compared using spearman rank correlation coefficient Decision trees analysis including Classification and regression trees to be used to identify the factors and subgroups predicting the outcomes General linear regression model to be used to identify the factors predicting the change in the SOFA score A p value 005 to be considered as statistically significant Statistical analysis to be performed using software Statistical package for social sciences version 23 SPSS-23 and MedCalc
Also septic shock has very high mortality rates In India Divatia JV et al observed that mortality in septic shock patients was 534 and Chatterjee et al observed it to be 628 Mortality rate according to different geographical locations have variations but still consistently high 228 mortality in Greece ICUs 79 in Turkish ICUs observed by Baykara et al in Japan 27 in Taiwan 438 in China 519
Disseminated intravascular coagulation DIC is prevalent entity in sepsisseptic shock patients as observed in different studies Ko BS et al observed prevalence to be 176 Dhainut JF et al found it to be 289 Saito et al in Japan to be 29 and J Kienast et al in Germany observed it to be 407
DIC itself has high mortality 291 407 50 and as high as 56 Mortality rates further increases when DIC co exists with severe sepsis as seen 676 by Ogura H et al 446 vs 553 without and with DIC respectively seen by Hayakawa et al 117 vs 541 without and with DIC respectively seen by Solanki D et al
Septic shock patients are at high risk of develop multiple organ dysfunction MODS In fact both DIC score and organ dysfunction were found increased in patients with septic shock as compared to patients without septic shock so the resultant higher mortality and MODS Studies also found mortality risk further increases in septic shock patients with the presence of DIC
Methodology Study design This prospective observational study will be conducted at the Department of Critical Care Medicine in collaboration with the Department of Haematology SGPGIMS Lucknow after the approval from the Institutional Ethics Committee IEC Study protocol During the study period all adult ICU participants with the diagnosis of septic shock will be considered as per inclusion and exclusion criteria DIC scores and SOFA scores will be calculated and followed-up for the 14 days
Definition and scores Septic shock is defined as a subset of sepsis in which particularly profound circulatory cellular and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone Participants with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure of 65 mmHg or greater and serum lactate level greater than 2mmolL in the absence of hypovolemia Sepsis -3 recommendations DIC score for overt and non-overt DIC will be used as per International Society on Thrombosis and Haemostasis ISTH Sample collection for DIC score calculation Blood samples will be collected as below Baseline sampling At inclusion Second sampling At 72 hours 12 hours Third sampling After 72 hours 12 hours of second sampling Data collections Demographic and relevant clinical characteristics of included participants will be collected on structured case report form
Sample size and statistical analysis Based on the study conducted by the H Ogura et al 2014 SOFA score was during the day 1 10738 to day 4 8950 Change in score Cohen d effect size 0398 At minimum two-sided 95 confidence and 80 power of the study minimum estimated sample size for the study is 52 Finally minimum 60 participants to be enrolled in the study Sample size was estimated using software Gpower version 3197 Descriptive statistics of the continuous variables will be presented as mean SD Median IQR whereas categorical variables in Frequency To compare the observations between baseline to follow-up data quantitative variable with the outcomes two-way repeated measures ANOVA will be used One way Analysis of covariance to be used to compare the post observations into outcomes after the adjusting the baseline measurements Change in the SOFA score with change in the DIC score to be compared using spearman rank correlation coefficient Decision trees analysis including Classification and regression trees to be used to identify the factors and subgroups predicting the outcomes General linear regression model to be used to identify the factors predicting the change in the SOFA score A p value 005 to be considered as statistically significant Statistical analysis to be performed using software Statistical package for social sciences version 23 SPSS-23 and MedCalc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None