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Evolution and Clinical Outcomes in Patients Undergoing Liver Transplantation

2017年4月9日 更新者:Maria Isabel Toulson Davisson Correia、Federal University of Minas Gerais

Evolution of Nutritional Status, Metabolic, Functional and Clinical Outcomes in Patients Undergoing Liver Transplantation

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.

調査の概要

状態

わからない

詳細な説明

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.

Resting Energy Expenditure - REE was measured by indirect calorimetry using Quark RMR® (Cosmed, Rome, Italy). The energy balance (EB) was obtained by subtracting the total energy expenditure from the total caloric intake (TCI). The total energy expenditure (TEE) was obtained by multiplying the 24-hour REE by the calculated activity factor (AF), which was based on the description of the patients' daily activities and the corresponding computed values of metabolic equivalents (METs). Food intake was assessed by a 3-day food record (Avanutri Online® (Avanutri Equipamentos de Avaliação Ltda, Rio de Janeiro, Brazil).

Clinical and other variables - Age, sex, etiology, severity of liver disease by the Model for End Stage Liver Disease score (MELD), complications like presence of fluid retention and hepatic encephalopathy; number of medication and diuretics; β-blockers and lactulose use were all compiled. The indications for liver transplantation were categorized into alcoholic cirrhosis, viral and other diseases.

In the second part of the study the patients evaluated in the pre-transplant who underwent transplantation were assessed in relation to the same parameters evaluated in the pre-transplant: nutritional, functional, metabolic, body composition, anthropometric, food intake and balance energy. For a description of the evolution of variables comparing the pre- and post-transplantation and evaluate the association of the variables evaluated the clinical outcomes of patients.

For the study about the prevalence of metabolic changes after liver transplantation in late post-transplant period, another population was evaluated. Patients undergoing liver transplantation between the years 2001-2014, which had data in medical records up to at least one year after surgery were included. To assess the prevalence and factors associated with hyperkalemia, information collected was: sex, age, underlying disease indication for transplantation, medication use, potassium, urea, creatinine and sodium values. Immunosuppressive drugs were: tacrolimus use and dose prescribed, and the residual dose; cyclosporine use and dose; prednisone use and dose. The use of other drugs included: furosemide, spironolactone, propranolol, captopril and enalapril.

To assess the prevalence of hypertension, diabetes and overweight according different doses of immunosuppression the presence of these conditions were collected from diagnosis described in the medical record of the patient, as well as the use of hypoglycemic agents and insulin medications will be evaluated; as well as the use of anti-hypertensive drugs. If the last weight registered in the medical record (post-transplant) subtracted from the weight recorded in the pre-transplant period will be considered. Those patients record that had water retention in the preoperative period, the estimated dry weight is considered. Those patients record that had water retention in the preoperative period, the estimated dry weight is considered. To do so, it will be contemplated from subtracting the estimated amount of liquid ascites and / or edema of the then current weight.

研究の種類

観察的

入学 (予想される)

70

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

    • Minas Gerais
      • Belo Horizonte、Minas Gerais、ブラジル
        • 募集
        • Hospital of Clinics of the University Federal of Minas Gerais
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Patients on the waiting list for liver transplant at the University Hospital of University Federal of Minas Gerais.

説明

Inclusion Criteria:

  • Patients on the waiting list for liver transplant
  • Over 20 years old
  • Accepted the terms of survey

Exclusion Criteria:

  • Under 20 years old
  • Fulminant hepatitis
  • Re-transplant
  • Double transplant

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 観測モデル:コホート
  • 時間の展望:見込みのある

コホートと介入

グループ/コホート
Waiting list for liver transplant
Patients on the waiting list for liver transplant treated at ambulatory liver transplant of Hospital of Clinics of the Federal University of Minas Gerais
Undergoing liver transplantation
Patients undergoing liver transplantation treated at ambulatory liver transplant of Hospital of Clinics of the Federal University of Minas Gerais

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Nutritional status
時間枠:December 2016
Subjective Global Assessment
December 2016

二次結果の測定

結果測定
メジャーの説明
時間枠
Functional status
時間枠:December 2016
Dinamometry Heart rate variability Six minute walk test
December 2016
Metabolic status
時間枠:December 2016
Resting Energy Expenditure Energetic Balance
December 2016

その他の成果指標

結果測定
メジャーの説明
時間枠
Metabolic status after liver transplantation
時間枠:December 2016
Hyperkalemia
December 2016
Metabolic status long term after liver transplantation
時間枠:December 2016
Diabetes mellitus Hypertension Overweight
December 2016

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Helem Ribeiro、helemsena@gmail.com

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2013年7月1日

一次修了 (予想される)

2017年10月1日

研究の完了 (予想される)

2017年11月1日

試験登録日

最初に提出

2016年8月11日

QC基準を満たした最初の提出物

2016年9月26日

最初の投稿 (見積もり)

2016年9月28日

学習記録の更新

投稿された最後の更新 (実際)

2017年4月11日

QC基準を満たした最後の更新が送信されました

2017年4月9日

最終確認日

2017年4月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • FU Minas Gerais

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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