Effect of Disseminated Intravascular Coagulation (DIC) Score Changes on Organ Dysfunction in Septic Shock Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 7
研究概览
简要总结
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.
详细描述
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 31.5 million per year. Divatia JV et al found incidence of severe sepsis and septic shock 28.3% in study covering different ICUs in India. Rhee C et al found incidence of severe sepsis and septic shock as high as 52.8%. Marx,G., et al observed incidence of septic shock in German ICUs to be 12.6 % whereas Mulatu HA et al found it to be 26.5% 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 53.4 % and Chatterjee et al observed it to be 62.8%. Mortality rate according to different geographical locations have variations but still consistently high: 22.8% mortality in Greece ICUs, 79% in Turkish ICUs observed by Baykara et al in Japan 27%, in Taiwan 43.8%, in China 51.9 %.
Disseminated intravascular coagulation (DIC) is prevalent entity in sepsis/septic shock patients as observed in different studies: Ko BS et al observed prevalence to be 17.6%, Dhainut J.F et al found it to be 28.9%, Saito et al in Japan to be 29% and J Kienast et al in Germany observed it to be 40.7%.
DIC itself has high mortality: 29.1%, 40.7%, 50% and as high as 56%. Mortality rates further increases when DIC co exists with severe sepsis as seen 67.6% by Ogura H et al, 44.6% vs. 55.3 % without and with DIC respectively seen by Hayakawa et al, 11.7% vs. 54.1% 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ICU patients having septic shock as defined by Sepsis -3 definition requiring vasopressor for at least 12 hours duration will be considered.
排除标准
- •Patient having septic shock duration either less than 12 hours or more than 24 hours at the time of the inclusion
- •Age less than 18 years or more than 65 years
- •Expected survival less than 72 hours
- •Caregiver refused for the consent to participate in the study
结局指标
主要结局
Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 7
时间窗: At day 7 after inclusion
Correlation of Disseminated Intravascular Coagulation score (0 to 8, where higher score is severe) and its change with the organ dysfunction measured as Sequential Organ Failure Assessment score (0 to 24, where higher score has worse outcome)
次要结局
- Effect of Disseminated Intravascular Coagulation score changes on organ dysfunction in septic shock patients at day 14(At day 14 after inclusion)
研究者
Mohan Gurjar
Professor
Sanjay Gandhi Postgraduate Institute of Medical Sciences