no secretin administered. All observations

32 mcg (<50kg) or 40 mcg (≥50kg) secretin two times a day (40 mcg; q 12 hrs)

32 mcg (<50kg) or 40 mcg (≥50kg) secretin four times a day (40 mcg; q 6 hrs)

32 mcg (<50kg) or 40 mcg (≥50kg) secretin six times a day (40 mcg; q 4 hrs)

Pancreatitis, Acute

Secretin

Dartmouth Hitchcock Medical Center

Secretin for Acute Pancreatitis

A Phase II Study to Establish the Efficacy of Synthetic Human SecretiN in Human Acute Pancreatitis (SNAP) Study

Change in serum C-reactive protein (CRP) level by 50% within 96 hours and/or at discharge compared with CRP level at admission to determine optimal frequency of dosing

Serum measurements of pro- and anti-inflammatory cytokines including sCD40L, EGF, Eotaxin/CCL11, FGF-2, Flt-3 ligand, Fractalkine, G-CSF, GM-CSF, GRO, IFN-α2, IFN-γ, IL-1α, IL-1β, IL-1ra, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p40), IL-12 (p70), IL-13, IL-15, IL-17A,IP-10, MCP-1, MCP-3, MDC (CCL22), MIP-1α, MIP-1β, PDGF-AA, PDGF-AB/BB, RANTES, TGF-α, TNF-α, TNF-β, VEGF, HSP 27, HSP 60, HSP 70, HSP 90 at time of study enrollment, days of secretin administration, 96 hours and at discharge

Change in blood urea nitrogen from admission

A cumulative measurement of the following parameters: (as referenced from the CRF) higher values represent worse outcome Organ Failure (number of systems) x 100 (each system) SIRS (number of criteria) x 25 (each criteria) Abdominal Pain (1-10) x 5 Morphine Equivalent Dose (mg) X 5 Tolerating Solid Diet (yes = 0, no = 1) X 40

Rate will be recorded as number of subjects readmitted within 30 days of final study treatment

ChiRhoClin, Inc.

Dartmouth-Hitchcock Medical Center

The study is not blinded and does not require any randomization codes. Ten patients each will receive one of three treatments for Days 1, 2, and 3:
No secretin - standard of care and observation (Cohort X)
32 mcg (<50kg) or 40 mcg (≥50kg)IV Bolus every 12 hours (Cohort 1)
32 mcg (<50kg) or 40 mcg (≥50kg)IV Bolus every 6 hours (Cohort 2)
32 mcg (<50kg) or 40 mcg (≥50kg)IV Bolus every 4 hours (Cohort 3)

secretin/nekroz

Secretin for Acute Pancreatitis

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