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The effect of Aminophylline in the treatment of patients with sepsis and septic shock: a prospective, randomized controlled trial

The effect of Aminophylline in the treatment of patients with sepsis and septic shock: a prospective, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019173
Enrollment
Unknown
Registered
2018-10-29
Start date
2018-11-05
Completion date
Unknown
Last updated
2019-09-09

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

Conditions

sepsis and septic shock

Interventions

Aminophylline group: Receive a infusion of Aminophylline 3mg/kg within 30 min and followed by an infusion at 0.4mg/kg/h for 5 days
control group:Based on standard of care

Sponsors

the First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Conform to the Society of Critical Care Medicine (SCCM)/the European Society of Intensive Care Medicine (ESICM) of sepsis criteria for diagnosis of sepsis-3: 1. Suspected or confirmed infection: clinical doctors diagnose; 2. An acute change in total SOFA scores 2 points consequent to the infection. The baseline SOFA score can be assumed to be zero in patients not known to have preexisting organ dysfunction.

Exclusion criteria

Exclusion criteria: 1. younger than 18 years old or older than 70 years old; 2. pregnancy or lactation; 3. New York heart association class 4 of congestive heart failure,acute myocardic infarction,malignant arrhythmia, non-infectious cardiogenic shock, uncontrolled acute blood loss; 4. solid organ or bone marrow transplant recipients;Rounding out the top; 5. received cardiopulmonary resuscitation (CPR) within 72 hours; 6. evidence of leukopenia, neutrophil count (ANC) absolutely < 0.5 x 10^9/L; 7. received high-dose corticosteroids before evaluation, namely received methylprednisolone 500 mg/day, use more than 3 days; 8. HIV positive; 9. blood/lymphatic system tumor without remission; 10. don't gain consent or authorization; 11. take part in screening for other exploratory clinical trials?within 6 months; 12. systolic blood pressure is greater than 140 mmHg or diastolic blood pressure is greater than 90 mmHg; 13. uremia.

Design outcomes

Primary

MeasureTime frame
mortality;

Secondary

MeasureTime frame
Duration of mechanical ventilation;Length of hospitalization in ICU;Number of organ failure;Infection site;Pathogenic bacterium;Oxygenation index;Vital signs;Urine volume;APACHE II score;SOFA score;Biochemical index;PCT;Routine blood examination;blood coagulation tests;C-reactive protein;

Countries

China

Contacts

Public ContactTongwen Sun

the First Affiliated Hospital of Zhengzhou University

suntongwen@163.com+86 13838516916

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026