Refeeding Syndrome in Cancer Patients

NCT ID: NCT02534181

Last Updated: 2018-01-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-02-28

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.

Conditions

Refeeding Syndrome; Cancer; Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Patients will undergo a caloric management protocol:

Days 1 and 2:

1. Reduction of caloric intake to 5kcal/kg/day;

2. Replacement of serum phosforus, potassium and magnesium;

3. Administration of 100mg intravenous thiamine, vitamins and microelements.

From day 3:

1. If serum phosphorus < 2.5mg/dL, protocol will be followed according to day 2;

2. If serum phosphorus > 2.5mg/dL, a gradual increase to target caloric intake will ensue.

Group Type: ACTIVE_COMPARATOR

Caloric Management Protocol

Intervention Type: DRUG

Strategy based on reduction of nutritional intake and electrolyte replacement.

Control group

1. Nutritional management will be followed according to institutional protocol.

2. Electrolyte replacement will be provided at the clinician's discretion.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Caloric Management Protocol

Strategy based on reduction of nutritional intake and electrolyte replacement.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Eduardo Atsushi Osawa

ICU Consultant Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ludhmila A Hajjar, MD, PhD

Role: STUDY_CHAIR

Director, Intensive Care Unit, Institute of Cancer of State of Sao Paulo

Eduardo A Osawa, MD, PhD

Role: STUDY_DIRECTOR

Physician, Intensive Care Unit, Institute of Cancer of State of Sao Paulo

Ilana Roitman

Role: PRINCIPAL_INVESTIGATOR

Nutritionist, Intensive Care Unit, Institute of Cancer of State of Sao Paulo

Clarice H Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Physician, Intensive Care Unit, Institute of Cancer of State of Sao Paulo

Gisele Queiroz, MD

Role: PRINCIPAL_INVESTIGATOR

Physician, Intensive Care Unit, Institute of Cancer of State of Sao Paulo

Related Links

http://www.icesp.org.br

Related Info

Other Identifiers

1.015.415

Identifier Type: -

Identifier Source: org_study_id