Clinical trial NCT02534181: Refeeding Syndrome in Cancer Patients
Official title: Refeeding Syndrome in Cancer Patients Admitted to Adult Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Refeeding Syndrome
Cancer
Critical Illness
Keywords: Refeeding Syndrome
Cancer
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2015-08-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether a nutritional strategy is effective in critically ill patients with cancer diagnosed with refeeding syndrome.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Initiation of any type of nutrition (enteral, parenteral or glucose solution of at least 10% concentration) in the ICU in the last 48 hours;
* Reduction of serum phosphorus to a level below 2.5mg/dL with a drop above 0.5mg/dL compared to a previous measurement;
* Caloric intake greater than 500kcal in the last 24 hours;
* Central venous access for electrolyte replacement;
* Signature of the informed consent form.

Exclusion Criteria:

* Use of enteral or parenteral nutrition before ICU admission;
* Prediction of ICU discharge in the following 2 days;
* End-stage renal disease;
* Admission for diabetic ketoacidosis or hyperosmolar hyperglycemic state;
* Recent treatment of hyperphosphatemia;
* Parathyroidectomy surgery;
* Participation in another study;
* Refusal to participate in the study.

Primary outcomes:
measure: Logistic Organ Dysfunction Score
timeFrame: 72 hours
Secondary outcomes:
measure: ICU length of stay
timeFrame: 30 days
measure: Hospital length of stay
timeFrame: 30 days
measure: Days in mechanical ventilation
timeFrame: 30 days
measure: Days in vasopressor therapy
timeFrame: 30 days
measure: Cardiovascular events
timeFrame: 30 days
measure: Delirium
timeFrame: 30 days
measure: Acute kidney injury
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Renal Replacement Therapy
timeFrame: 30 days
measure: Acute ischemic stroke
timeFrame: 30 days
measure: Seizures
timeFrame: 30 days
measure: Adverse events
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Director, Intensive Care Unit, Institute of Cancer of State of Sao Paulo
name: Ludhmila A Hajjar, MD, PhD
role: STUDY_CHAIR
affiliation: Physician, Intensive Care Unit, Institute of Cancer of State of Sao Paulo
name: Eduardo A Osawa, MD, PhD
role: STUDY_DIRECTOR
affiliation: Nutritionist, Intensive Care Unit, Institute of Cancer of State of Sao Paulo
name: Ilana Roitman
role: PRINCIPAL_INVESTIGATOR
affiliation: Physician, Intensive Care Unit, Institute of Cancer of State of Sao Paulo
name: Clarice H Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Physician, Intensive Care Unit, Institute of Cancer of State of Sao Paulo
name: Gisele Queiroz, MD
role: PRINCIPAL_INVESTIGATOR
References: