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The efficacy and safety of posterior pituitary hormone in early refractory septic shock

The efficacy and safety of posterior pituitary hormone in early refractory septic shock

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082478
Enrollment
Unknown
Registered
2024-03-29
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

septic shock

Interventions

2groups:Pituitrin (2u/h intravenously pumped)

Sponsors

Northern Jiangsu People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Each patient must meet all of the following inclusion criteria in order to be included in the study: (1) Adult patients with refractory septic shock aged = 18 years are defined as those who require a total dose of norepinephrine of = 0.5 µ g/kg/min (converted to norepinephrine equivalent as shown in Table 1) to maintain mean arterial pressure (MAP) between 55-70 mmHg for a period of no more than 6 hours. (2) The patient has placed a central venous catheter and undergone invasive blood pressure monitoring, which has been present for at least the first 48 hours of the study. (3) The patient must receive at least 25mL/kg of crystal or colloid equivalent within the first 24 hours and undergo sufficient fluid resuscitation according to the opinion of the treatment researcher. (4) Patients must meet the diagnostic criteria for septic shock, which include persistent hypotension after sufficient volume resuscitation, the need for vasoactive drugs to maintain mean arterial pressure (MAP) = 65 mmHg, and serum lactate levels>2 mmol/L. (5) The patient or legal representative is willing and able to provide written informed consent and comply with all protocol requirements.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following exclusion criteria are not eligible for inclusion in the study: (1) Patients under 18 years old. (2) Pregnant women (3) Patients with concomitant acute coronary syndrome. (4) Liver failure patients with end-stage liver function child C grading. (5) Patients with acute mesenteric ischemia or a history of mesenteric ischemia. (6) Patients with a history of aortic dissection or abdominal aortic aneurysm, with the presence or high suspicion of having aortic dissection or abdominal aortic aneurysm. (7) Patients who require a daily dose of 500 mg or more of hydrocortisone or equivalent glucocorticoid drugs as a routine dose. (8) Patients with Renault's phenomenon, systemic sclerosis, or vascular spasms.

Design outcomes

Primary

MeasureTime frame
Response of mean arterial pressure at 3 hours after the start of infusion;

Secondary

MeasureTime frame
Time to meet MAP = 65mmHg standard;Equivalent demand for catecholamines;Application time of vasoactive drugs;Lactic acid compliance time;CRRT time;Mechanical ventilation time;

Countries

China

Contacts

Public ContactXiaolan Xu

Northern Jiangsu People’s Hospital

xpuxuxiaolan86@163.com+86 189 5257 8265

Outcome results

None listed

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