Continuous Renal Replacement Therapy (CRRT) in Surgery Room During Orthotopic Liver Transplantation (OLT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- central venous pressure average values at the end of treatment
研究概览
简要总结
The study is interventional, non-pharmacological, single-center. The aim of this study is to test the possible added value of CRRT in the surgery room during liver transplantation, compared to the investigators center current practice in which CRRT is suspended and possibly restarted at the end of the operation. The incidence of some clinical and metabolic alterations that often complicate transplantation in the absence of CRRT will be evaluated, by measuring a series of parameters related to the state of water filling, acid-base balance, general metabolic structure, hemodynamics and supportive drugs.
Some parameters related to patient safety will be evaluated. The results of this exploratory study will be useful to document what was rationally hypothesized, that is, that the continuation of dialysis treatment even during the hours of surgery, in this narrow category of patients, is actually useful to reduce the possible clinical and metabolic complications, intra- and/or post-operative (within 48 hours of transplant), linked to the simultaneous presence of renal failure.
The statistical analysis is aimed at analyzing the behavior of different indicators of clinical complications and comparing them with what was found in the historical series, in the hypothesis that with the new procedure the analyzed parameters are better. In detail, the mean values at the end of treatment will be compared for:
- Central venous pressure
- Potassiemia
- Lactatemia
- pH
The following will also be evaluated:
- dose of vasoconstrictor drugs, defined by the variation between the dose at the beginning of administration during the anhepatic phase and the maximum dose reached
- pulmonary congestion/pulmonary edema, defined by radiological signs of alveolar congestion/edema on chest X-ray in the post-surgery period
- safety parameters: episodes of hypokalemia requiring supplementation (K<3.5 mmol/l), post-surgery hypophosphatemia, number of coagulation events in the extracorporeal circuit, appearance of cardiac arrhythmias.
详细描述
The study is interventional, non-pharmacological, single-center. The clinical practice adopted to date provides that upon arrival of the liver to be transplanted, dialysis is interrupted before entering the surgery room, and then resumed, if necessary, upon exiting the room. The aim of this study is to test the possible added value of CRRT in the surgery room during liver transplantation, compared to the investigators center current practice. The incidence of some clinical and metabolic alterations that often complicate transplantation in the absence of CRRT will be evaluated, by measuring a series of parameters related to the state of water filling, acid-base balance, general metabolic structure, hemodynamics and supportive drugs. Some parameters related to patient safety will be evaluated.
For each patient enrolled in the study, the following will be collected:
baseline data (taken before entering the operating room), intraoperative data, postoperative data for the first 48 hours, and data at 3 and 6 months after surgery.
Baseline data:
- demographic data: age, sex
- anamnestic data: etiology of liver disease (viral, alcoholic, neoplastic, other); state of liver disease (acute, acute on chronic, cirrhosis, decompensated cirrhosis); etiology of acute kidney injury (sepsis, hypovolemia/hemorrhage, iatrogenic/drugs, hepatorenal syndrome, other); indication for dialysis treatment (uremia, electrolyte imbalance, acidosis, oligo-anuria, fluid overload, other)
- biochemical parameters (as indicated in the "Objectives" paragraph): pH, HCO3, pO2, pCO2, BE, P/F ratio, DO2, SVO2; hemoglobin, hematocrit, sodium, potassium, calcium, lactate, CPK, ammonium, glycemia
- Hemodynamic parameters: heart rate, mean arterial pressure, cardiac output, peripheral vascular resistance, central venous pressure, pulmonary wedge pressure, stroke volume
- Severity scores: MELD and SOFA pre- and post-intervention
- Other clinical data: amine infusion (YES/NO), mechanical ventilation (YES/NO), urine output (volume/minute), radiological signs of pulmonary congestion/edema (YES/NO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for ISOLATED LIVER TRANSPLANT with acute or chronic renal failure already undergoing continuous dialysis treatment in Intensive Care at the time of arrival of the organ. If acute renal failure: stage 2-3 of the KDIGO classification (referring to diuresis).
- •Patients scheduled for COMBINED LIVER-KIDNEY TRANSPLANT, whether or not they are already undergoing continuous dialysis treatment in Intensive Care at the time of arrival of the organ to be implanted
- •Patients scheduled for ISOLATED LIVER TRANSPLANT, for acute liver failure and with acute renal failure in stage 3 of the KDIGO classification (referring to diuresis) for which there is an indication for continuous dialysis.
- •Age ≥ 18 years
- •Signature of informed consent
排除标准
- •Age < 18 years
研究组 & 干预措施
CRRT during OLT
CRRT during OLT
干预措施: continuous renal replacement therapy (Other)
结局指标
主要结局
central venous pressure average values at the end of treatment
时间窗: during surgery
Central venous pressure (cmH2O)
Potassiemia average values at the end of tretment
时间窗: during surgery
Potassiemia (mmol/L)
Lactatemia average values at the end of treatment
时间窗: during surgery
Lactatemia (mmol/L)
pH average values at the end of treatment
时间窗: during surgery
pH (absolute value)
次要结局
- dose of vasocostrictors drugs(during surgery)
- pulmunary congestion(during surgery)
- safety parameters: episodes of hypokalemia(during surgery)
- safety parameters: post-surgery hypophosphatemia(during surgery)
- safety parameters: number of coagulation events in the extracorporeal circuit(during surgery)
- Safety parameters: appearance of cardiac arrhythmias(during surgery)