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Hemodynamic Response to Norepinephrine in Critically Ill Adults with Septic Shock: A Propensity Score-Matched Comparison of Cirrhotic and Non-cirrhotic Patients

Hemodynamic Response to Norepinephrine in Critically Ill Adults with Septic Shock: A Propensity Score-Matched Comparison of Cirrhotic and Non-cirrhotic Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20251108003
Enrollment
200
Registered
2025-11-08
Start date
2025-10-26
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Adult critically ill cirrhotic and non-cirrhotic patients admitted to medical intensive care units with septic shock Cirrhosis, sepsis, septic shock, hemodynamic, critically ill, norepinephrine, vasopressors

Interventions

Critically ill cirrhotic patients admitted to medical intensive care units with septic shock and received norepinephrine for maintaining mean arterial pressure more than 65 mm Hg,Matched critically il
Other,Other
Cirrhotic patients,Non-cirrhotic patients

Sponsors

None listed

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Patients aged more than 18 years 2) Admission to the medical intensive care unit 3) Diagnosis of sepsis or septic shock according to Sepsis-3 definition 4) Hypotension requiring norepinephrine and/or another vasopressor to maintain a mean arterial pressure (MAP) more than 65 mmHg and adequate tissue perfusion

Exclusion criteria

Exclusion criteria: 1) Shock due to causes other than sepsis (e.g., hemorrhagic shock, cardiogenic shock, obstructive shock) 2) Massive hemorrhage requiring massive transfusion 3) Moribund patients or those with an expected life expectancy < 24 hours 4) Patients with do-not-resuscitate (DNR) orders 5) Missing of key physiological data for the analysis (heart rate, blood pressure, norepinephrine or vasopressor infusion rate)

Design outcomes

Primary

MeasureTime frame
Time to achieve MAP 65 mm Hg after norepinephrine initiation WIthin 24 hours of norepinephrine initiation Time from norepinephrine initiation to time that MAP above 65 mm Hg

Secondary

MeasureTime frame
Proportion of patients achieve MAP 65 mm Hg at 6 h, 12 h, and 24 h 6, 12, and 24 hours after norepinephrine initiation Number of patients who maintain MAP above 65 mm Hg at 6, 12, and 24 hours after norepinephrine initiation,Maximum norepinephrine dose in mcg/kg/min within 24 hours of ICU admission Within 24 hours after ICU admission Maximum norepinephrine dose in mcg/kg/min the patient received within the first 24 hours of ICU admission,Norepinephrine dose in mcg/kg/min at 1, 2, 6, 12, 24 h after norepinephrine initiation 1, 2, 6, 12, and 24 hours after norepinephrine initiation Norepinephrine dose in mcg/kg/min the patient received at each time point,Hemodynamic parameters (HR, SBP, DBP, MAP) at 1, 2, 6, 12, 24 h after norepinephrine initiation 1, 2, 6, 12, and 24 hours after norepinephrine initiation Vital signs measured by monitor at each time point,Derived hemodynamic parameters (SI, DSI, MSI, AASI, AMSI, RASI, blood pressure response index) at 1, 2, 6, 12, 24 h after norepinephrine initiation 1, 2, 6, 12, and 24 hours after norepinephrine initiation Hemodynamic parameters calculated from vital signs parameters at each time point,Requirement of additional vasopressors or inotropes 24 hours after ICU admission Use of second or third vasopressors or inotropes (such as Adrenaline, Dopamine, Terlipressin, Dobutamine, Milrinone),Lactate clearance 6, 12, and 24 hours after norepinephrine initiation Rate of lactate reduction in percent calculated by [(Initial Lactate - Lactate at a later time) / Initial Lactate] x 100%,Time to shock resolution During ICU admission Duration between start of vasopressor therapy and cessation of vasopressor therapy,Total fluid administered at 6 h and 24 h after onset of shock 6 and 24 hours after shock onset Total amount of fluid administered at 6 hours and 24 hours after shock onset in mL,Vasopressor-free days at 28 days after ICU admission Within 28 days after ICU admission Patient survival and the duration of time a patient is alive

Countries

Thailand

Contacts

Public ContactNatdanai Ketdao

Division of Critical Care, Department of Medicine, Khon Kaen University

natdke@kku.ac.th0880684998

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026