Clinical trial · Interventional

Refeeding Syndrome in Cancer Patients

Refeeding Syndrome in Cancer Patients Admitted to Adult Intensive Care Unit

NCT02534181CI-TRIAL-00031139RESCUEwithdrawnPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Logistical issues

Summary

Brief summary (as posted)

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

Conditions

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer	Malignant Neoplasm	ALIAS	0.90
Critical Illness	—	UNRESOLVED	—
Refeeding Syndrome	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Caloric Management Protocol	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Intervention group
description
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.
interventionNames
1. Drug: Caloric Management Protocol
type
NO_INTERVENTION
label
Control group
description
1. Nutritional management will be followed according to institutional protocol. 2. Electrolyte replacement will be provided at the clinician's discretion.

Primary outcomes (1)

measure
Logistic Organ Dysfunction Score
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.