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出境医 / 临床实验 / Prognostic Potential of Preoperative Nutritional Status and Postoperative Change in Patients Undergoing Hip Arthroplasty (NUTRIANCA)
Prognostic Potential of Preoperative Nutritional Status and Postoperative Change in Patients Undergoing Hip Arthroplasty (NUTRIANCA)
Study Description
Brief Summary:
Data literature lacks of evidence concerning the variation of the nutritional status in patients undergoing hip surgery, thus preventing an effective application a nutritional support program. It is therefore necessary to start identifying the clinical steps (pre-operative and post-operative) that may be defined as critical control points for malnutrition. The observation should foresee the identification of nutritional status indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery. This study aims to investigate the prognostic nutritional factors that might influence clinical outcomes, and their variation in relation to hospitalization and rehabilitation periods.
| Condition or disease |
|---|
| Hip Arthropathy Malnutrition; Anemia Frail Elderly Syndrome |
Detailed Description:
Data literature lacks of evidence concerning the variation of the nutritional status in patients undergoing hip surgery, thus preventing an effective application a nutritional support program. It is therefore necessary to start identifying the clinical steps (pre-operative and post-operative) that may be defined as critical control points for malnutrition. Patients undergoing hip surgery would be enrolled before the surgical operation and would be evaluated three times: preoperative, postoperative, and after discharge. The observation should foresee the identification of nutritional status indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery. This study aims to investigate the prognostic nutritional factors that might influence clinical outcomes, and their variation in relation to hospitalization and rehabilitation periods.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 60 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prognostic Potential of the Preoperative Nutritional Status and Its Postoperative Variation in Patients Undergoing Hip Arthroplasty |
| Actual Study Start Date : | May 31, 2019 |
| Estimated Primary Completion Date : | April 2021 |
| Estimated Study Completion Date : | April 2022 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- Change from baseline level of hemoglobin at 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ]One of the main decision-making factors that guide the clinician to discharge the patient is the hemoglobin level. The association between preoperative hemoglobin and hemoglobin at discharge was already observed in past orthopedic cohorts, with a loss of 3.3 g/dl being considered clinically relevant. Patients with a better nutritional status may have a reduced fall in hemoglobin after the surgical operation.
Secondary Outcome Measures :
- Change from baseline level of pre-albumin at 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ]Pre-albumin (mg/dl)
- Change from baseline level of total lymphocyte count at 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ]Total lymphocyte count (cells/mm^3)
- Change from baseline level of iron at 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ]Iron (μg/dl)
- Change from baseline level of vitamin D at 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ]25[OH]D (ng/ml)
- Change from baseline of weight 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ]Weight (kg)
- Change from baseline of calf circumference 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ]Calf circumference (cm)
- Change from baseline of % of fat mass at 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ]Bioelectrical impedance analysis (% of fat mass and % of lean mass)
- Change from baseline of hand-grip strength at 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ]Hand-grip strength (kg). For this test, the higher values, the better is.
- Change from baseline of FIM test at 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ]Functional Independence Measure (FIM) (18-126 point scale). For this test, the higher values, the better is.
- Change from baseline of 10 meter walking test at 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ]10 meter walking test (m/s). For this test, the higher values, the better is.
- Change from baseline of POMA at 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ]Performance Oriented Mobility Assessment (POMA) (0-32 point scale). For this test, the higher values, the better is.
Eligibility Criteria
| Ages Eligible for Study: | 60 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Primary care clinic
Criteria
Inclusion Criteria:
- caucasian
- arthroplasty intervention program with hip prosthesis placement
- signature and acceptance of informed consent to collaborate in all the procedures necessary for the study
Exclusion Criteria:
- heart failure stage III-IV
- renal failure stage III-IV
- actual cancer
- past neurological disorders (including, but not limited to cerebral ischemia, cerebral haemorrhages, brain tumors, endocranial aneurysms)
- neurodegenerative disorders (including, but not limited to Alzheimer's dementia, fronto-temporal dementia)
- actual major psychopharmacological therapies
- pregnancy certified by self-declaration
- inability to adhere to the rehabilitation protocol or to carry out the controls
- non-acceptance of informed consent
- revision interventions
- previously established and documented sleep disorders
- shift or part-time worker
Contacts and Locations
Contacts
| Contact: Matteo Briguglio | 00393386087042 | docmatteobriguglio@gmail.com | |
| Contact: Elena Cittera | elena.cittera@grupposandonato.it |
Locations
| Italy | |
| IRCCS Istituto Ortopedico Galeazzi | Recruiting |
| Milan, Italy | |
| Contact: Matteo Briguglio | |
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
Investigators
| Principal Investigator: | Matteo Briguglio | IRCCS Istituto Ortopedico Galeazzi |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 22, 2019 | ||||||||
| First Posted Date | June 10, 2019 | ||||||||
| Last Update Posted Date | August 30, 2019 | ||||||||
| Actual Study Start Date | May 31, 2019 | ||||||||
| Estimated Primary Completion Date | April 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Change from baseline level of hemoglobin at 14 days after surgical operation [ Time Frame: Before the surgical operation, after 3 days, after 14 days. ] One of the main decision-making factors that guide the clinician to discharge the patient is the hemoglobin level. The association between preoperative hemoglobin and hemoglobin at discharge was already observed in past orthopedic cohorts, with a loss of 3.3 g/dl being considered clinically relevant. Patients with a better nutritional status may have a reduced fall in hemoglobin after the surgical operation.
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Prognostic Potential of Preoperative Nutritional Status and Postoperative Change in Patients Undergoing Hip Arthroplasty | ||||||||
| Official Title | Prognostic Potential of the Preoperative Nutritional Status and Its Postoperative Variation in Patients Undergoing Hip Arthroplasty | ||||||||
| Brief Summary | Data literature lacks of evidence concerning the variation of the nutritional status in patients undergoing hip surgery, thus preventing an effective application a nutritional support program. It is therefore necessary to start identifying the clinical steps (pre-operative and post-operative) that may be defined as critical control points for malnutrition. The observation should foresee the identification of nutritional status indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery. This study aims to investigate the prognostic nutritional factors that might influence clinical outcomes, and their variation in relation to hospitalization and rehabilitation periods. | ||||||||
| Detailed Description | Data literature lacks of evidence concerning the variation of the nutritional status in patients undergoing hip surgery, thus preventing an effective application a nutritional support program. It is therefore necessary to start identifying the clinical steps (pre-operative and post-operative) that may be defined as critical control points for malnutrition. Patients undergoing hip surgery would be enrolled before the surgical operation and would be evaluated three times: preoperative, postoperative, and after discharge. The observation should foresee the identification of nutritional status indicators, such as weight, hemoglobin, albumin, food intake, and others that might affect a proper recovery. This study aims to investigate the prognostic nutritional factors that might influence clinical outcomes, and their variation in relation to hospitalization and rehabilitation periods. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Primary care clinic | ||||||||
| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
60 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | April 2022 | ||||||||
| Estimated Primary Completion Date | April 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 60 Years to 85 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | Italy | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03981354 | ||||||||
| Other Study ID Numbers | NUTRIANCA | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Istituto Ortopedico Galeazzi | ||||||||
| Study Sponsor | Istituto Ortopedico Galeazzi | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Istituto Ortopedico Galeazzi | ||||||||
| Verification Date | August 2019 | ||||||||
