Refeeding Syndrome in Cancer Patients (RESCUE)

Refeeding Syndrome in Cancer Patients Admitted to Adult Intensive Care Unit

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

Study Overview

• Status: Withdrawn
• Conditions: Cancer; Critical Illness; Refeeding Syndrome
• Intervention / Treatment: Drug: Caloric Management Protocol

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; Patients will undergo a caloric management protocol: Days 1 and 2: Reduction of caloric intake to 5kcal/kg/day;; Replacement of serum phosforus, potassium and magnesium;; Administration of 100mg intravenous thiamine, vitamins and microelements. From day 3: If serum phosphorus < 2.5mg/dL, protocol will be followed according to day 2;; If serum phosphorus > 2.5mg/dL, a gradual increase to target caloric intake will ensue.	Drug: Caloric Management Protocol; Strategy based on reduction of nutritional intake and electrolyte replacement.
No Intervention: Control group; Nutritional management will be followed according to institutional protocol.; Electrolyte replacement will be provided at the clinician's discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Logistic Organ Dysfunction Score	Score of the number and severity of organ failures during ICU stay	72 hours

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Chair: Ludhmila A Hajjar, MD, PhD, Director, Intensive Care Unit, Institute of Cancer of State of Sao Paulo; Study Director: Eduardo A Osawa, MD, PhD, Physician, Intensive Care Unit, Institute of Cancer of State of Sao Paulo; Principal Investigator: 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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: August 23, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Actual): January 10, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Cancer; Refeeding Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease; Nutrition Disorders; Malnutrition; Syndrome; Critical Illness; Refeeding Syndrome
• Other Study ID Numbers: 1.015.415