Health Condition 1: K830- Cholangitis
Conditions
Interventions
Intervention1: Urgent Biliary Drainage (as early as possible and within 12 hours after gastroenterology consultation in the Emergency Department: Urgent biliary drainage within 12 hours
Control Interv
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with severe acute cholangitis as defined by Tokyo guidelines 2018, as follows. It will be defined as acute cholangitis that is associated with the onset of dysfunction at least in one of the following organs/systems: 2. Cardiovacular dysfunction: hypotension requiring dopamine greater than or equal to 5 g/kg/min or any dose of norepinephrine/epinephrine. 3. Neurological dysfunction: any disturbance in consciousness. 4. Respiratory dysfunction: PaO2/FiO2 less than 300. 5. Renal dysfunction: oliguria, serum creatinine greater than 2.0 mg/dl 6. Hepatic dysfunction: PT-INR greater than 1.5 7. Hematological dysfunction: platelet count less than 100,000/cumm
Exclusion criteria
Exclusion criteria: 1. Patient with age less than 18 or greater than 70 years. 2. Patients with refractory shock requiring dopamine greater than 15 mcg/kg/min or epinephrine greater than 0.3 mcg/kg/min or norepinephrine greater than 0.3 mcg/kg/min or requiring two inotropic drugs simultaneously 3. Patients on mechanical ventilation due to severe respiratory failure or poor GCS (less than 6) 4. Moribund patients with expected survival less than a month such as advanced malignancy 5. Severe co-morbidities such as decompensated cirrhosis or chronic renal failure or congestive heart failure. 6. Pregnancy 7. Patient with malignant hilar obstruction, Bismuth Corlette type II-IV 8. Patients refusing consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30 days all cause mortality and a hierarchical composite outcome of change in clinical status during the 30 days of treatment will be dual primary endpoint. Hierarchical composite outcome will be defined as below. 1) Death within 30 days. 2) Patient who did not die but had one or more worsened organ failures. 3) Patient having no organ failures but hospitalized till day 30. 4) Patient alive, without any Organ failure, and discharged prior to day 30.Timepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical and Technical SuccessTimepoint: 30 days;2. New onset of organ failure or worsening of existing organ failure within 30 days.Timepoint: 30 days;Adverse events within 30 days after randomizationTimepoint: 30 days | — |
Countries
India
Contacts
Public ContactSoumya Jagannath Mahapatra
All India Institute of Medical Sciences
Outcome results
None listed