Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue
Conditions
Interventions
Intervention1: Resveratrol and copper: 1. Resveratrol and copper will be administered via Ryle’s tubes every 6 hr on empty stomach (4 times a day).
2. 5.6 mg of Resveratrol suspended in 10 ml of water
Sponsors
TRAC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18 -70 years 2. Hemato-lymphoid malignancy 3. Febrile neutropenia with expected duration of neutropenia >7 days 4. Need of ICU admission
Exclusion criteria
Exclusion criteria: 1. History of Resveratrol and/or copper intake in dietary supplements in last 3 week 2. Patient admitted after cardiopulmonary resuscitation 3. Patients on warfarin 4. Underlying advance malignancy with no treatment option 5. Chronic renal failure with GFR 6. Chronic liver dysfunction/cirrhosis 7. Pregnancy (urinary pregnancy kit for females of reproductive age group) 8. Known case of HIV/AIDS. 9. Moribund patient unlikely to survive for >48 hours at the time of screening as judged by the treating intensivist based on the presence of severe multi-organ dysfunction and shock despite resuscitation at the time of screening as assessed by any of the following parameters (not limited to): ? Inability to maintain MAP >65 mm Hg on doses of noradrenaline or adrenaline exceeding 0.66 mic/kg/min or ? Inability to maintain MAP >65 mm Hg on combination of vasopressin with either noradrenaline or adrenaline ? Severe lactic acidosis (pH 8 mmol/L) in spite of fluid resuscitation, vasopressors and ventilator support. ? The ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2 to FiO2 or PF ratio) = 100.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ICU MortalityTimepoint: At Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with Reversal Of Organ Failure as defined by= 2points reduction in SOFA score at the 7th day of ICU admission compared to on-admission SOFA score without taking Platelets count in the considerationTimepoint: Day 7;ICU MortalityTimepoint: Day 28;Ventilator free daysTimepoint: Day 7;Vasopressor free daysTimepoint: Day 7;Renal replacement therapy requirementsTimepoint: Any time during ICU stay | — |
Countries
India
Contacts
Public ContactDr Amol Kothekar
Tata Memorial Hospital
Outcome results
None listed