Effect of cumulative fluid balance on delirium predicted by CAM-ICU and functional near-infrared spectroscopy (fNIRS) guided mapping of frontal cortex in critically ill patients with septic shock- a prospective observational study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AIIMS
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- To analyze the correlation of day-7 cumulative fluid balance with the incidence of delirium, during the first 7 days of ICU admission.
研究概览
简要总结
For patients admitted with septic shock to Intensive Care Unit of All India Institute of Medical sciences, New Delhi, the sensors of fNIRS (NIRSport) monitor will be placed on day 1,4,7 and clinical, laboratory, hemodynamic parameters including CAM-ICU score, the cumulative fluid balance will be recorded for 7 days after ICU admission. The treating physicians will be blinded to the case enrollment and the observed outcome of interest. An independent investigator apart from the treating ICU team will assess the daily fluid balance and another investigator will assess for delirium and fNIRS readings at various time points from day 1 to day 7 after ICU admission. Administration of antibiotics, source control, vasopressors, inotropic agents, glucocorticoids, insulin, IV albumin, blood products, renal replacement therapy, nutrition. Use of diuretics will be at the discretion of the treating physician and the same will be noted. Delirium bundle (ABCDEF) will be followed in all patients enrolled for the study, to curtail the effect of confounding factors. All the collected data will be tabulated in Microsoft Excelâ„¢ [Microsoft Corp., Redmond, Washington], and statistical analysis will be performed using SPSS 20.0 software (SPSS Inc, Chicago, Illinois, USA). The statistical analysis of fNIRS data (change in Oxyhemoglobin values in mmol/dl) will be done using NIRSLABv2019.4 using SPM (Statistical Parametric Mapping) and MATLAB 2022 (Mathworks Ltd.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Admitted to the ICU within 24 hours of having been diagnosed with septic shock.
- •Defined by Sepsis-3 consensus guidelines as a suspected or confirmed source of infection with Sequential organ failure assessment (SOFA) more than or equal to 2 and shock.
- •Shock is defined as hypotension requiring persistent vasopressor therapy to maintain mean arterial pressure (MAP) of more than 65 mmHg and serum lactate levels greater than 2 mmol per L despite adequate initial fluid resuscitation (at least 30ml per kg of IBW).
排除标准
- •Patients on short term mechanical ventilation less than 48 hours.
- •A pre-ICU diagnosis of cognitive dysfunction as indicated by their medical records on admission, or a primary central nervous system diagnosis like cerebrovascular accident, meningitis, seizure disorder, psychiatric disorder, hypoxic encephalopathy post cardiac arrest.
- •Death before assessment of ICU-delirium within 3 days of ICU admission.
- •Life-threatening bleeding, the presence of hemorrhagic shock, as judged by research or treating clinicians.
- •Burns, Pregnancy.
- •Referral from or treated at other healthcare facilities.
- •Patients with a likely extracerebral source of serum S100B elevation (e.g., severe disabling neuromuscular disorders, severe burns, advanced malignancy, polytrauma, and chronic renal failure).
- •Readmission to ICU.
- •Withdrawal of consent.
结局指标
主要结局
To analyze the correlation of day-7 cumulative fluid balance with the incidence of delirium, during the first 7 days of ICU admission.
时间窗: From day 1 to day 7 after ICU admission
次要结局
- To study the association of cumulative fluid balance with the changes in frontal cortex using fNIRS in patients with delirium.(on day1, 4 and 7 after ICU admission)
- To assess the correlation of cumulative fluid balance with the average days of delirium (CAM-ICU positive days)
- To assess the correlation of cumulative fluid balance with the average comatose (RASS -4 and-5) days(From day 1 to day 7 after ICU admission)
- To assess the correlation of cumulative fluid balance with the severity of delirium using CAM-ICU-7 Delirium Severity Scale(From day 1 to day 7 after ICU admission)
- To assess the effect of other risk factors of delirium.(From day 1 to day 7 after ICU admission)
研究者
Meenupriya Arasu
All India Institute of Medical Sciences, New Delhi