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Effect of early intravenous use of the ß-blocker esmolol on the prognosis of acute pancreatitis patients to control heart rate

Effect of early intravenous use of the ß-blocker esmolol on the prognosis of acute pancreatitis patients to control heart rate

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080160
Enrollment
Unknown
Registered
2024-01-22
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Acute Pancreatitis

Interventions

Esmolol group:Patients randomly assigned to Esmolol Group were initiated within 1 hour of enrolling in esmolol for 96 hours at a starting intravenous dose of 25 mg/h followed by an incremental rate of
Standard Care group:Patients randomly assigned to the Standard Care group, according to the clinical practice of the center, the Standard Care group was used as the control group in this study without

Sponsors

Jinling Hospital affiliated to Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. AP patients within 3 days of new onset 2. Predicted severe acute pancreatitis (APACHEII=8 or CRP>150mg/L) 3. After fluid resuscitation treatment (6h after the start of fluid resuscitation), the heart rate is still =110bpm and sustains for at least 10 minutes 4. Age = 18 years old 5. Obtain informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who have been treated with ß receptor blockers before admission; 2. Patients with chronic cardiac insufficiency (NYHA patients above grade III); 3. Pregnant and lactating patients; 4. Patients with bronchial asthma attack or history of bronchial asthma; 5. Patients with severe chronic obstructive pulmonary disease (requiring home oxygen therapy); 6. Patients who are expected to die within 24 hours; 7. Patients with contraindications to ß receptor blockers (including severe sinus bradycardia, atrioventricular block above the first degree, cardiogenic shock, sick sinus syndrome, decompensated heart failure, pulmonary hypertension, untreated pheochromocytoma, etc.)

Design outcomes

Primary

MeasureTime frame
Organ failure free days to day 14;

Secondary

MeasureTime frame
Proportion of patients whose heart rate recovered to less than 95bpm 24h after enrollment;Proportion of patients whose heart rate recovered to less than 95bpm 48h after enrollment;Proportion of patients whose heart rate recovered to less than 95bpm 72h after enrollment;Proportion of patients whose heart rate recovered to less than 95bpm 96h after enrollment;mortality;incidence of intensive care unit admission;Sequential organ failure assessment(SOFA) score at 24h, 48h, 72h, 96h, 7 days, 14 days after enrollment ;The incidence of bleeding requiring intervention;The incidence of gastrointestinal perforation or fistula;The incidence of pancreatic fistula;The proportion of enteral nutrition meeting the standard at Day7 and Day14;The proportion of new onset organ failure;The proportion of new onset requiring mechanical ventilation;The proportion of new onset requiring renal replacement therapy;Proportion of new onset requiring vasoactive drug therapy;The proportion requiring minimally invasive drainage;Proportion of patients requiring open surgery;Length of index hospital stay;First admission cost;Heart rate variability(HRV) at 24h after admission;Heart rate variability(HRV) at 48h after admission;Heart rate variability(HRV) at 72h after admission;Heart rate variability(HRV) at 96h after admission;Changes in plasma gastrin between day1 and day5;Changes in plasma Interleukin-6 between day1 and day5;Changes in plasma C-reactive protein(CRP) between day1 and day5;Changes in pancreatitis activity scoring system(PASS) score from day1 to day7;Changes in systemic inflammatory response syndrome(SIRS) score from day1 to day7;Intensive care unit free days to day14;Ventilator-free days to day14;Vasopressor-free days to day 14;Renal replacement therapy-free survival to day 14;Systemic inflammatory response syndrome-free days to day14;

Countries

China

Contacts

Public ContactLi Weiqin

Jinling Hospital affiliated to Nanjing University

ctgchina@medbit.cn+86 139 5183 9654

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026