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临床试验/CTRI/2024/11/076244
CTRI/2024/11/076244尚未招募不适用

utility of delta lactate for predicting early allograft dysfunction in adult patients undergoing liver transplantations- A prospective observational study

Department of Liver anaesthesia and critical care1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月20日最近更新:

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

发起方
Department of Liver anaesthesia and critical care
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Elavarasan

Dr Rela institute and medical center

研究点 (1)

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