NCT02534181

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2015

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

August 23, 2015

Last Update Submit

January 8, 2018

Conditions

Refeeding SyndromeCancerCritical Illness

Keywords

Refeeding SyndromeCancer

Outcome Measures

Primary Outcomes (1)

  • Logistic Organ Dysfunction Score

    Score of the number and severity of organ failures during ICU stay

    72 hours

Secondary Outcomes (12)

  • ICU length of stay

    30 days

  • Hospital length of stay

    30 days

  • Days in mechanical ventilation

    30 days

  • Days in vasopressor therapy

    30 days

  • Cardiovascular events

    30 days

  • +7 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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.

Drug: Caloric Management Protocol

Control group

NO INTERVENTION

1. Nutritional management will be followed according to institutional protocol. 2. Electrolyte replacement will be provided at the clinician's discretion.

Interventions

Caloric Management ProtocolDRUG

Strategy based on reduction of nutritional intake and electrolyte replacement.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Refeeding SyndromeNeoplasmsCritical Illness

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ICU Consultant Physician

Study Record Dates

First Submitted

August 23, 2015

First Posted

August 27, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

January 10, 2018

Record last verified: 2018-01