utility of delta lactate for predicting early allograft dysfunction in adult patients undergoing liver transplantations- A prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the change in lactate over 12 hours (delta lactate 0-12) as an early marker for early allograft dysfunction in Living donor liver transplant recipient (LDLTR) in early post-op period
研究概览
简要总结
Liver transplantation (LT) is the definitive treatment for patients with end-stage liver disease
The postoperative course following LT can be complicated by a variety of graft dysfunctions, ranging from Early Allograft dysfunction (EAD) to primary non-function of the liver graft
EAD has been shown to have a negative impact on early postoperative complications such as Acute kidney injury (AKI), Sepsis, biliary issues leading to prolonged ICU and hospital stay and, in some instances, decreased patient survival
Lactate is a metabolite produced from pyruvate by the enzyme lactate dehydrogenase (LDH), which is involved in glycolysis during normal metabolism and exercise
Under physiological conditions, approximately 1500 mmol of lactate is produced daily and metabolized predominantly in the liver (approximately 60 %), kidneys (approximately 30 %), and other organs
Reduction in lactate levels, improvement in core temperature and improvement in urine output were considered early signs of good allograft function
Lactate clearance after transplantation is also considered a good surrogate marker of liver graft function. This association has also been demonstrated in previous studies
Hyperlactatemia at the end of liver resection surgery was an independent risk factor for postoperative morbidity
Static lactate values in the immediate postoperative period after LT have been established as useful markers for increased hospital stay and ICU mortality.
In contrast, dynamic indices of lactate metabolism, which measure the magnitude of change over time, should be more useful in predicting outcomes. Hence, we conducted a study to evaluate the decrease in lactate over time and its association with graft dysfunction
Intraoperative lactate levels will be checked every 1-2 hours, including immediately after reperfusion of the liver graft. After admission to the ICU after LT, lactate levels will be checked every 2nd hourly till it is less than 2 mmol/L and 4th hourly thereafter for 24 hours and then daily till discharge from the ICU. Lactate clearance [delta lactate, that is, ∆ lactate] will be calculated as the reduction rate of lactate between the time of reperfusion and admission to the ICU as follows:
∆ lactate0-12 = [Lactate at 30 minutes after reperfusion – Lactate at 12 hrs after reperfusion]
Lactate level at 30 minutes after reperfusion
Continuous variables are expressed as medians with interquartile ranges, and categorical data are presented as percentages, as appropriate. Continuous variables will be compared using the Mann–Whitney U test, and categorical variables will be compared using the chi-squared test or Fisher’s exact test. Receiver operating characteristic (ROC) curves will be used to examine the accuracy of lactate. Statistical analyses were performed using IBM SPSS for Windows version 20.0 (Armonk, NY, USA
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients aged between 18-65 years who are undergoing living donor liver transplantation at our institution.
排除标准
- •Age less than 18 years Patient refusal Diagnosed with infections like Empyema, spontaneous bacterial peritonitis intra-operatively AKI within 7 days prior to transplant, in the preoperative period Patient posted for re-exploration/surgery within POD
- •Patient on CRRT – intra op and post operative.
结局指标
主要结局
To evaluate the change in lactate over 12 hours (delta lactate 0-12) as an early marker for early allograft dysfunction in Living donor liver transplant recipient (LDLTR) in early post-op period
时间窗: 8 weeks
次要结局
- To evaluate the change in lactate over 6 hours (delta lactate 0-6) and 24 hours (delta lactate 0-24) as markers for early allograft dysfunction in LDLTR in the early postoperative period. To examine the association between delta lactate levels and postoperative incidence of sepsis, AKI, prolonged mechanical ventilation, and biliary complications. To examine the association between delta lactate levels and length of hospital stay, ICU stay, and 30-day and 90-day mortality rates(from POD - 0 to discharge from hospital, with 30 day and 90 day mortality)
研究者
Elavarasan
Dr Rela institute and medical center
