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The clinical effect of intravenous infusion of hydroxyamine compared with noradrenaline in septic shock: a multicenter randomized controlled clinical study

The clinical effect of intravenous infusion of hydroxyamine compared with noradrenaline in septic shock: a multicenter randomized controlled clinical study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027116
Enrollment
Unknown
Registered
2019-11-01
Start date
2019-11-01
Completion date
Unknown
Last updated
2019-11-04

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

Conditions

Sepsis shock

Interventions

experimental group:Hydroxylamine
control group:Noradrenaline

Sponsors

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Sign informed consent; 2. At least 18 years old; 3. Meet the diagnosis process and specific criteria of septic shock (3.0). 4. The use time of noradrenaline / dopamine before enrollment is less than 4h.

Exclusion criteria

Exclusion criteria: 1. Acute coronary syndrome (acute myocardial infarction during shock, confirmed by the patient's history, ECG or changes of myocardial Enzymology); 2. In the current ICU, hydroxyamine was used for arterial blood pressure support before admission. 3. Patients with irreversible or dying conditions determined by researchers; 4. Pregnant women; 5. Confirmed or suspected acute mesenteric ischemia and Raynaud's phenomenon; 6. Organ transplantation; 7. Shock caused by non infectious factors; 8. Hyperthyroidism; 9. Serious arrhythmia.

Design outcomes

Primary

MeasureTime frame
28 day mortality;

Secondary

MeasureTime frame
Changes of SOFA score 7 days after admission;Time of deviating from vasoactive drugs;Time of MAP reaching standard after medicationr administration;Use of open-label vasoactive drugs;Serious adverse events during medication;ICU length of stay;

Countries

China

Contacts

Public ContactAijun Pan

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

aijunpan868@sina.com+86 13866668786

Outcome results

None listed

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