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.
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
Brazil1 site, 1 recruiting
- Recruiting
Hospital of Clinics of the University Federal of Minas Gerais
Belo Horizonte, Minas Gerais
Isabel Correia, isabel_correia@uol.com.br
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.
- Conditions
- Liver Disease, Nutrition Disorders
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Subjective Global Assessment
Measured: December 2016
Secondary outcomes (2)
Functional status
Dinamometry Heart rate variability Six minute walk test
Measured: December 2016
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.
- First posted28 Sep 2016 (estimated)
- Study startJul 2013
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Isabel Toulson Davisson Correia, Federal University of Minas Gerais
- Investigators
- Helem Ribeiro, Principal investigator, helemsena@gmail.com
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Nutritional Status, Metabolic, Functional and Clinical Outcomes in Patients Undergoing Liver Transplantation
- ClinicalTrials.gov ID
- NCT02917382
- Acronym / sponsor ID
- FU Minas Gerais
- Conditions
- Liver Disease, Nutrition Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on the waiting list for liver transplant at the University Hospital of University Federal of Minas Gerais.
Key inclusion criteria (3 listed)
- Patients on the waiting list for liver transplant
- Over 20 years old
- Accepted the terms of survey
Key exclusion criteria (4 listed)
- Under 20 years old
- Fulminant hepatitis
- Re-transplant
- Double transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nutritional status
Time frame: December 2016
Subjective Global Assessment
2 secondary outcomes
Functional status
Time frame: December 2016
Metabolic status
Time frame: December 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel Correia contact
Helem Ribeiro principal investigator
helemsena@gmail.com
1 site in 1 country: see every site and its status.
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.