Evolution of Nutritional Status, Metabolic, Functional and Clinical Outcomes in Patients Undergoing Liver Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Nutritional status
研究概览
简要总结
Liver transplantation (LTx) is the standard treatment used in the final stage of chronic or acute liver failure. The success for the LT depends on many factors. One of the factors related to morbidity and mortality of these patients is malnutrition. Patients on the waiting list for LTx are increased risk of malnutrition and metabolic disorders that may be associated with decreased functional capacity, change in resting energy expenditure cardiac autonomic dysfunction. These conditions may influence the results both before and after transplantation, as the clinical outcome and complications present in the postoperative period. Therefore, this study aims to characterize and relate nutritional status, metabolic, functional and clinical outcomes in the recent postoperative patients undergoing liver transplantation. It is an observational, prospective study based on four evaluations: the first will be conducted while the patient is awaiting transplantation; and after insertion of the graft, patients will be evaluated between the 1nd and 3th postoperative day, between 5 and 7 days and at discharge from hospital.
In the late post-transplant, there is the action of immunosuppressive drugs, largely responsible for increased survival, but also on the other hand, are responsible for important nutritional and metabolic disorders. Metabolic complications such as hyperkalemia, hypertension, diabetes mellitus and overweight have been described. Thus, due to the high incidence of these complications, alternative options, such as lowering the dose of immunosuppressive drugs, have been fully explored, particularly as regards association with the viability of the graft. However, few studies have evaluated whether there is change in the incidence of metabolic disorders, cited above, in relation to the different doses of immunosuppressive drugs. Furthermore these metabolic complications will be evaluated in the late post-transplant period.
详细描述
This study was carried out at the Alfa Institute of Gastroenterology, Hospital of Clinics, Universidade Federal of Minas Gerais (UFMG). The research protocol was approved by the UFMG Ethics Committee. Patients with indication for liver transplantation, aged over 20 years who regularly attended the Liver Outpatient Transplant Clinic were included after having agreed and signed the informed consent form. Patients on the waiting list for a double or re-transplant were excluding conditions.
Nutritional status was provided by the Subjective Global Assessment (SGA), adapted for patients on the waiting list for liver transplantation is based on clinical history and physical examination, as well as the presence of existing conditions such as encephalopathy, chronic or recurrent infection, varicose veins and renal function.
Anthropometric evaluation was comprised of weight, height, body mass index (BMI), triceps and subscapular skinfold thickness (TSF and SSF respectively, measured with the Lange Skinfold Caliper - Cambridge Scientific Industries Inc., Cambridge, MD, USA), and arm muscle area (AMA). To minimize practical variability, the average of three consecutive measurements was recorded.
Functional parameters were evaluated by Handgrip strength (HS), 6-minute walk test (6MWT) and heart frequency variability (HFV). HS was assessed with the Jamar Handgrip Dynamometer (Preston, Jackson, MI, USA) using the non-dominant arm, and the mean of three measurements was determined. The 6MWT was performed indoors, in a 30m long, flat corridor with an adequate surface and the gait speed during the 6MWT was collected. The HRV was assessed using short-term evaluation. The heart rate recording was acquired by RS800 CX (Polar, Finland) and a 5-min stable cardiac recording was analyzed to assess the time domain (SD of all normal-to-normal interval [SDNN]).
Bioelectrical impedance analysis (Quantum X - RJL Systems, Inc., Clinton Township, Michigan) was used to determine body composition. Measurements were made with patients lying in bed with 4 electrodes attached to the dorsum of the right hand and foot. Phase angle (PA), fat mass (FM - kg), fat free mass (FFM, kg), total body water (TBW - L), intracellular water (ICW - L) and extracellular water (ECW - L), were evaluated.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients on the waiting list for liver transplant
- •Over 20 years old
- •Accepted the terms of survey
排除标准
- •Under 20 years old
- •Fulminant hepatitis
- •Re-transplant
- •Double transplant
结局指标
主要结局
Nutritional status
时间窗: December 2016
Subjective Global Assessment
次要结局
- Functional status(December 2016)
- Metabolic status(December 2016)
研究者
Maria Isabel Toulson Davisson Correia
PHD
Federal University of Minas Gerais