Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Vitamin D (Arachitol): Injection Vitamin D (Arachitol)
Dose: 0.5ml containing 3,00,000 IU.
Duration: Single dose.
Route of administration: Intramuscular in deltoid muscle.
Timing: Be
Sponsors
AIIMS Mangalagiri
Eligibility
Inclusion criteria
Inclusion criteria: Patients scheduled for emergency laparotomy (e.g., for bowel obstruction, perforation, ischemia, or any acute abdomen requiring emergency midline laparotomy) Surgery planned within 24 hours of admission
Exclusion criteria
Exclusion criteria: Patients with a known history of primary hyperparathyroidism Severe comorbidities (end-stage renal disease, active malignancy, severe hepatic impairment) Use of immunosuppressive medications or corticosteroids Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in plasma levels of pro-inflammatory markers (IL-6, CRP) and anti-inflammatory marker (IL-10)Timepoint: 0 hours, 24-hours, 72-hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feasibility Proportion of eligible patients recruited and completing the protocol, timing of administration of Vitamin D after randomization before laparotomy.Timepoint: 0 hours;2. Safety hypercalcemia (serum calcium, phosphorus)Timepoint: 0 hours, 24-hours, 72-hours;3. Post-operative outcome- a. Length of ICU stay, length of hospital stays.Timepoint: 30 days;3. Post-operative outcome- b. New onset organ dysfunction, worsening of pre-operative acute organ dysfunctionTimepoint: 30 days;3. Post-operative outcome- c. Requirement of organ support (mechanical ventilation-duration/days, dialysis-number of sessions, number of blood transfusions, cardiac support-inotropes- number, duration/days, requirement of total parenteral nutrition).Timepoint: 30 days;3. Post-operative outcome- d. Post-operative systemic complications Cardiac- arrythmias, respiratory-pneumonia, pleural effusion, renal- acute renal failure, jaundice, thrombocytopenia.Timepoint: 30 days;3. Post-operative outcome- e. Post-operative regional complications (abdomen) intra-abdominal collection, paralytic ileus, othersTimepoint: 30 days;3. Post-operative outcome - f. Post-operative surgical site complications surgical site infection as per CDC criteria, seroma, hematoma, wound dehiscence, others.Timepoint: 30 days;3. Post-operative outcome- g. Clavien-Dindo grading of post-operative complications.Timepoint: 30 days;3. Post-operative outcome- h. Survival till 30 daysTimepoint: 30 days;4.To explore potential associations between baseline vitamin D levels and inflammatory responses i.e., subgroup analysis between baseline low vitamin D and normal vitamin D level patients.Timepoint: 0 hours, 24-hours, 72-hours | — |
Countries
India
Contacts
Public ContactDr Mallikarjun Gunjiganvi
AIIMS Mangalagiri
Outcome results
None listed