Refeeding SyndromePhase 2RESCUENCT02534181
Refeeding Syndrome in Cancer Patients
A Phase 2 study testing Caloric Management Protocol in people with Refeeding Syndrome and Cancer, run by University of Sao Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refeeding Syndrome, Cancer, Critical Illness
- What is being tested?
- Caloric Management Protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Feb 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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
- Being tested
- Caloric Management Protocol
- Keywords
- Refeeding Syndrome, Cancer
- Medical subject headings
- Refeeding Syndrome, Neoplasms, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric Management ProtocolDrug
Strategy based on reduction of nutritional intake and electrolyte replacement.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Logistic Organ Dysfunction Score
Score of the number and severity of organ failures during ICU stay
Measured: 72 hours
Secondary outcomes (12)
ICU length of stay
Number of days in the ICU
Measured: 30 days
Hospital length of stay
Number of days in hospital
Measured: 30 days
Days in mechanical ventilation
Number of days in mechanical ventilation
Measured: 30 days
Days in vasopressor therapy
Number of days using vasopressor therapy
Measured: 30 days
Cardiovascular events
Incidence of acute ischemic event or acute heart failure
Measured: 30 days
Delirium
Incidence of delirium according to CAM-ICU
Measured: 30 days
Acute kidney injury
Incidence of acute kidney injury according to KDIGO
Measured: 30 days
Mortality
Incidence of all-cause mortality
Measured: 30 days
Renal Replacement Therapy
Number of days in renal replacement therapy
Measured: 30 days
Acute ischemic stroke
Incidence of acute ischemic stroke
Measured: 30 days
Seizures
Number of seizure episodes
Measured: 30 days
Adverse events
Number of episodes of the following events: hypoglycemia, diarrhea, ileous, nausea and vomiting.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016 (estimated)
- Study completionFeb 2017 (estimated)
Why it stopped: Logistical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refeeding SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Atsushi Osawa, University of Sao Paulo
- Investigators
- Ludhmila A Hajjar, MD, PhD, Study chair, Director, Intensive Care Unit, Institute of Cancer of State of Sao PauloEduardo A Osawa, MD, PhD, Study director, Physician, Intensive Care Unit, Institute of Cancer of State of Sao PauloIlana Roitman, Principal investigator, Nutritionist, Intensive Care Unit, Institute of Cancer of State of Sao PauloClarice H Park, MD, PhD, Principal investigator, Physician, Intensive Care Unit, Institute of Cancer of State of Sao PauloGisele Queiroz, MD, Principal investigator, Physician, Intensive Care Unit, Institute of Cancer of State of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534181
- Sponsor's protocol ID
- 1.015.415
- Acronym
- RESCUE
- Status last verified
- Jan 2018
- First submitted
- 23 Aug 2015
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refeeding Syndrome in Cancer Patients Admitted to Adult Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02534181
- Acronym / sponsor ID
- RESCUE / 1.015.415
- Conditions
- Refeeding Syndrome, Cancer, Critical Illness
- Keywords
- Refeeding Syndrome, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistical issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Drug: Caloric Management ProtocolPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric Management ProtocolStrategy based on reduction of nutritional intake and electrolyte replacement. | Drug | Intervention group |
Primary outcome
Logistic Organ Dysfunction Score
Time frame: 72 hours
Score of the number and severity of organ failures during ICU stay
12 secondary outcomes
ICU length of stay
Time frame: 30 days
Hospital length of stay
Time frame: 30 days
Days in mechanical ventilation
Time frame: 30 days
Days in vasopressor therapy
Time frame: 30 days
Cardiovascular events
Time frame: 30 days
Delirium
Time frame: 30 days
Acute kidney injury
Time frame: 30 days
Mortality
Time frame: 30 days
Renal Replacement Therapy
Time frame: 30 days
Acute ischemic stroke
Time frame: 30 days
Seizures
Time frame: 30 days
Adverse events
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Related InfoLink provided by the sponsor.
Related trials for Refeeding Syndrome
Not yet recruitingObservational study
Respiratory Quotient and Phosphate Changes During Early Critical Illness
Refeeding Syndrome, Critical Illness
Not yet recruitingObservational study
3-Dimensional Optical Scanning to Assess and Monitor Malnutrition in Eating Disorders (3D-ED) Study
Anorexia in Adolescence, Anorexia Nervosa
Not yet recruitingObservational study
Gastrointestinal Hormones and Metabolomic Profiling Following Mixed-Meal Tolerance Tests in Patients at Risk of Refeeding Syndrome
Refeeding Syndrome, Malnutrition
Active, not recruitingPhase 1
Slow Introduction of Nutrition for Ill Malnourished Children
Malnutrition, Severe Acute, Malnutrition, Child
Recruiting
Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
Critical Illness, Malnutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludhmila A Hajjar, MD, PhD study chair
Director, Intensive Care Unit, Institute of Cancer of State of Sao Paulo
Eduardo A Osawa, MD, PhD study director
Physician, Intensive Care Unit, Institute of Cancer of State of Sao Paulo
Ilana Roitman principal investigator
Nutritionist, Intensive Care Unit, Institute of Cancer of State of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caloric Management Protocol in people with Refeeding Syndrome and Cancer, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Logistic Organ Dysfunction Score (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.