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Logistical issues
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The purpose of this study is to evaluate whether a nutritional strategy is effective in critically ill patients with cancer diagnosed with refeeding syndrome.
Refeeding syndrome is a clinical entity triggered by the introduction of calories in chronically undernourished patients. A number of organs may be affected due to imbalance of fluids and electrolytes. In the intensive care setting, there are no formal guidelines to recommend the appropriate treatment of this condition. The aim of this study is to evaluate the implementation of a nutritional protocol to address cancer patients admitted to the ICU with refeeding syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Patients will undergo a caloric management protocol: Days 1 and 2:
From day 3:
|
|
| Control group | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caloric Management Protocol | Drug | Strategy based on reduction of nutritional intake and electrolyte replacement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Logistic Organ Dysfunction Score | Score of the number and severity of organ failures during ICU stay | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| ICU length of stay | Number of days in the ICU | 30 days |
| Hospital length of stay | Number of days in hospital | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ludhmila A Hajjar, MD, PhD | Director, Intensive Care Unit, Institute of Cancer of State of Sao Paulo | Study Chair |
| Eduardo A Osawa, MD, PhD | Physician, Intensive Care Unit, Institute of Cancer of State of Sao Paulo | Study Director |
| Ilana Roitman | Nutritionist, Intensive Care Unit, Institute of Cancer of State of Sao Paulo | Principal Investigator |
| Clarice H Park, MD, PhD | Physician, Intensive Care Unit, Institute of Cancer of State of Sao Paulo | Principal Investigator |
| Gisele Queiroz, MD | Physician, Intensive Care Unit, Institute of Cancer of State of Sao Paulo | Principal Investigator |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D055677 | Refeeding Syndrome |
| D009369 | Neoplasms |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D020969 | Disease Attributes |
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| Days in mechanical ventilation | Number of days in mechanical ventilation | 30 days |
| Days in vasopressor therapy | Number of days using vasopressor therapy | 30 days |
| Cardiovascular events | Incidence of acute ischemic event or acute heart failure | 30 days |
| Delirium | Incidence of delirium according to CAM-ICU | 30 days |
| Acute kidney injury | Incidence of acute kidney injury according to KDIGO | 30 days |
| Mortality | Incidence of all-cause mortality | 30 days |
| Renal Replacement Therapy | Number of days in renal replacement therapy | 30 days |
| Acute ischemic stroke | Incidence of acute ischemic stroke | 30 days |
| Seizures | Number of seizure episodes | 30 days |
| Adverse events | Number of episodes of the following events: hypoglycemia, diarrhea, ileous, nausea and vomiting. | 30 days |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |