Health Condition 1: R652- Severe sepsis
Conditions
Interventions
Intervention1: Terlipressin and Norepinephrine: Group 1 will receive combination of terlipressin 0.02 mcg/kg/min (fixed dose) and noradrenaline 0.01 mcg/kg/min titrating to maximum dose of 3mcg/kg/min
Sponsors
Hospital Supplies AIIMS Jodhpur
Eligibility
Inclusion criteria
Inclusion criteria: Patients older than 18 years diagnosed with septic shock during their ICU stay whose relatives give informed consent for the study will be considered for enrolment.
Exclusion criteria
Exclusion criteria: The following patients will be excluded from the study: 1. Patients whose relatives refuse to give consent for the study. 2. Unstable coronary artery syndrome (acute myocardial infarction during this episode of shock based on the combination of history, electrocardiogram and enzyme changes) or underlying cardiac dysfunction [cardiac index (CI) 3. Stroke or head injury. 4. Chronic renal failure on maintenance dialysis. 5. Malignancy or other irreversible disease or condition for which mortality was estimated to be very high (defined by investigator), 6. Acute mesenteric ischemia either proven or suspected 7. Raynaudâ??s phenomenon 8. Pregnancy 9. Organ transplantation. 10. Known hypersensitivity to norepinephrine or terlipressin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the dose of Norepinephrine required to achieve target MAP(65-70mm of Hg) .Timepoint: After 12 hours of starting the vasopressor. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Duration of vasopressor requirement. 2) Changes in lactate level at 12 hours after starting the infusion 3) Urine output in ml per hour at 12 hours after starting of infusion 4) Changes in the Sequential Organ Failure Assessment (SOFA) score after 12 hours of starting vasopressor infusion. 5) Incidence of serious adverse events like digital ischemia, cardiac arrhythmias, incidence of diarrhea and upper GI bleed. Timepoint: After 12 hours of starting the vasopressor. | — |
Countries
India
Contacts
Public ContactDr Pallavi Sahoo
All India Institute of Medical Sciences, Jodhpur
Outcome results
None listed