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Liver DiseaseNCT02917382

Evolution and Clinical Outcomes in Patients Undergoing Liver Transplantation

An observational study of Liver Disease and Nutrition Disorders, run by Federal University of Minas Gerais at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Liver Disease, Nutrition Disorders
How many people
70 participants
Where
1 siteBrazil
Study dates
Jul 2013to Nov 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Isabel Correia contact

isabel_correia@uol.com.br

Brazil1 site, 1 recruiting
  • Hospital of Clinics of the University Federal of Minas Gerais

    Belo Horizonte, Minas Gerais

    Isabel Correia, isabel_correia@uol.com.br

    Recruiting

Other trials in Brazil

About this study

Official title: 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.

Read the detailed description

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.

Medical subject headings
Liver Diseases, Nutrition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02917382
Study groupRoleWhat they receive
Waiting list for liver transplantPatients 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 transplantationPatients undergoing liver transplantation treated at ambulatory liver transplant of Hospital of Clinics of the Federal University of Minas Gerais

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nutritional status

    Subjective Global Assessment

    Measured: December 2016

Secondary outcomes (2)
  1. Functional status

    Dinamometry Heart rate variability Six minute walk test

    Measured: December 2016

  2. Metabolic status

    Resting Energy Expenditure Energetic Balance

    Measured: December 2016

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2016 (estimated)
  2. Study startJul 2013
  3. Primary completionOct 2017 (estimated)
  4. Study completionNov 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02917382
Sponsor's protocol ID
FU Minas Gerais
Status last verified
Apr 2017
First submitted
11 Aug 2016
Last updated
11 Apr 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Disease and Nutrition Disorders, run by Federal University of Minas Gerais at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Isabel Correia (isabel_correia@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nutritional status (time frame: December 2016). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.

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