Secretin for Acute Pancreatitis
Açar sözlər
Mücərrəd
Təsvir
This is a prospective, phase II exploratory pilot study using different dose frequencies of intravenous human secretin in patients with non-obstructive, interstitial acute pancreatitis. All enrolled patients will receive standard of care therapy in regard to fluid resuscitation, pain control, CT scan or ultrasound imaging and nutritional support. In addition to standard of care, patients will be divided into 4 cohorts of 10 patients. Cohorts 1,2 and 3 will receive different doses of intravenous synthetic human secretin. Cohort X will not receive drug. Dosing will start within 24 hours of hospitalization with no further secretin administration beyond Day 3. Patients will continue to be followed until discharge. The primary study endpoint will be the decrease 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. Secondary study endpoints will include: 1) 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 2) Clinically relevant outcome measures including hemoconcentration (fall in blood urea nitrogen and hematocrit from admission), decrease in patient admission pain scores (visual analogue scale), decrease in systemic inflammatory response, and tolerance of oral nutrition 3) Calculation of the Dynamic Acute Pancreatitis Score - organ failure, systemic inflammatory response syndrome, abdominal pain, requirement for opiates and ability to tolerate oral intake 4) Length of hospitalization, need for intensive care unit transfer, mortality, need for surgical, endoscopic or percutaneous intervention 5) Development of pancreatic necrosis and/or persistent organ failure and 6) Adverse events and 30 day readmission rate.
Tarixlər
| Son Doğrulandı: | 03/31/2019 |
| İlk təqdim: | 08/23/2018 |
| Təxmini qeydiyyat təqdim edildi: | 09/25/2018 |
| İlk Göndərmə: | 09/26/2018 |
| Son Yeniləmə Göndərildi: | 04/07/2019 |
| Son Yeniləmə Göndərildi: | 04/09/2019 |
| Həqiqi Təhsilin Başlama Tarixi: | 09/30/2018 |
| Təxmini İlkin Tamamlanma Tarixi: | 09/30/2019 |
| Təxmini İşin Tamamlanma Tarixi: | 10/31/2019 |
Vəziyyət və ya xəstəlik
Müdaxilə / müalicə
Drug: Secretin
Faza
Qol Qrupları
| Qol | Müdaxilə / müalicə |
|---|---|
| No Intervention: Cohort X no secretin administered. All observations | |
| Active Comparator: Cohort 1 32 mcg (<50kg) or 40 mcg (≥50kg) secretin two times a day (40 mcg; q 12 hrs) | |
| Active Comparator: Cohort 2 32 mcg (<50kg) or 40 mcg (≥50kg) secretin four times a day (40 mcg; q 6 hrs) | |
| Active Comparator: Cohort 3 32 mcg (<50kg) or 40 mcg (≥50kg) secretin six times a day (40 mcg; q 4 hrs) |
Uyğunluq Kriteriyaları
| Təhsil üçün uyğun yaşlar | 18 Years Üçün 18 Years |
| Təhsilə Uyğun Cinslər | All |
| Sağlam Könüllüləri qəbul edir | Bəli |
| Kriteriyalar | Inclusion Criteria: 1. Patient is male or female ≥18 years of age 2. Patient voluntarily signed written, informed consent agreement. 3. If patient is female and not more than 1 year post-menopausal, or surgically sterile, must use medically accepted form of contraception or abstain from sexual activities during study 4. Patient has acute pancreatitis as defined by the Atlanta Classification of 2012 5. No evidence of obstructive pancreatitis on available cross-sectional imaging Exclusion Criteria: 1. Pancreatitis with duct obstruction or severe acute pancreatitis defined by Atlanta Classification 2. Pregnant woman, nursing mothers, or women of childbearing potential not on birth control 3. Known adverse reaction to human secretin |
Nəticə
İlkin nəticə tədbirləri
1. Change in CRP level [96 hours and through study completion an average of day 7]
İkincili Nəticə Tədbirləri
1. Pro- and anti-inflammatory markers [Day 1, Day 2, Day 3, 96 hours and through study completion an average of day 7]
Digər nəticə tədbirləri
1. Change in Hemoconcentration measurement [96 hours and through study completion an average of day 7]
2. Change in Hemoconcentration measurements [96 hours and through study completion an average of day 7]
3. Acute Pancreatitis Activity Score [96 hours and through study completion an average of day 7]
4. Overall hospital stay [96 hours and through study completion an average of day 7]
5. Rate of Adverse Events [30 days following the last administration of study treatment]
6. Readmission Rate [30 days following the last administration of study treatment]
