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Refeeding Syndrome in Cancer Patients (RESCUE)

Primary Purpose

Refeeding Syndrome, Cancer, Critical Illness

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Caloric Management Protocol

About this trial

This is an interventional treatment trial for Refeeding Syndrome focused on measuring Refeeding Syndrome, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Logistic Organ Dysfunction Score

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

Secondary Outcome Measures

ICU length of stay

Number of days in the ICU

Hospital length of stay

Number of days in hospital

Days in mechanical ventilation

Number of days in mechanical ventilation

Days in vasopressor therapy

Number of days using vasopressor therapy

Cardiovascular events

Incidence of acute ischemic event or acute heart failure

Delirium

Incidence of delirium according to CAM-ICU

Acute kidney injury

Incidence of acute kidney injury according to KDIGO

Mortality

Incidence of all-cause mortality

Renal Replacement Therapy

Number of days in renal replacement therapy

Acute ischemic stroke

Incidence of acute ischemic stroke

Seizures

Number of seizure episodes

Adverse events

Number of episodes of the following events: hypoglycemia, diarrhea, ileous, nausea and vomiting.

Full Information

NCT ID

NCT02534181

First Posted

August 23, 2015

Last Updated

January 8, 2018

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02534181

Brief Title

Refeeding Syndrome in Cancer Patients

Acronym

RESCUE

Official Title

Refeeding Syndrome in Cancer Patients Admitted to Adult Intensive Care Unit

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Logistical issues

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refeeding Syndrome, Cancer, Critical Illness

Keywords

Refeeding Syndrome, Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Active Comparator

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Caloric Management Protocol

Intervention Description

Strategy based on reduction of nutritional intake and electrolyte replacement.

Primary Outcome Measure Information:

Title

Logistic Organ Dysfunction Score

Description

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

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

ICU length of stay

Description

Number of days in the ICU

Time Frame

30 days

Title

Hospital length of stay

Description

Number of days in hospital

Time Frame

30 days

Title

Days in mechanical ventilation

Description

Number of days in mechanical ventilation

Time Frame

30 days

Title

Days in vasopressor therapy

Description

Number of days using vasopressor therapy

Time Frame

30 days

Title

Cardiovascular events

Description

Incidence of acute ischemic event or acute heart failure

Time Frame

30 days

Title

Delirium

Description

Incidence of delirium according to CAM-ICU

Time Frame

30 days

Title

Acute kidney injury

Description

Incidence of acute kidney injury according to KDIGO

Time Frame

30 days

Title

Mortality

Description

Incidence of all-cause mortality

Time Frame

30 days

Title

Renal Replacement Therapy

Description

Number of days in renal replacement therapy

Time Frame

30 days

Title

Acute ischemic stroke

Description

Incidence of acute ischemic stroke

Time Frame

30 days

Title

Seizures

Description

Number of seizure episodes

Time Frame

30 days

Title

Adverse events

Description

Number of episodes of the following events: hypoglycemia, diarrhea, ileous, nausea and vomiting.

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: