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The effect of perfusion index monitoring compared to mean arterial blood pressure on norepinephrine dose adjustment and tissue perfusion parameters in septic shock patient

The effect of perfusion index monitoring compared to mean arterial blood pressure on norepinephrine dose adjustment and tissue perfusion parameters in septic shock patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250109064330N1
Enrollment
60
Registered
2025-02-24
Start date
2025-02-19
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

The study will include patients with septic shock hospitalized in the intensive care unit.. Severe sepsis with septic shock

Interventions

Intervention 1: In the intervention group dose adjustment will be done by monitoring the perfusion index through the MASIMO prop pulse oximeter in the Alborz B9 Saadat monitor
In this group, the researcher will reduce the dose of norepinephrine drug in the control group by 1 µ/min through the infusion pump every 20 minutes for 8 hours in order to maintain the minimum dose o

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria include the diagnosis of septic shock in patients by special care specialist and based on the latest SSC guidelines, including serum lactate more than 2 mmol/L and the need for norepinephrine infusion to create MAP=65 mm Hg after initial fluid resuscitation. It is with the possibility of infection. Age 18 years and older obtaining informed consent temperature greater than 36 degrees Celsius SOFA index greater than and equal to 2 the maximum time interval from the start of norepinephrine infusion to the start of the intervention should be 4 hours.

Exclusion criteria

Exclusion criteria: need for dialysis impaired detection of PI by sensors active bleeding arrhythmias affecting hemodynamics during intervention. history of cardiac and pulmonary resuscitation active hematological malignancy ESRD class B and C liver failure peripheral vascular diseases in the upper limbs

Design outcomes

Primary

MeasureTime frame
Creatinine level measurement. Timepoint: at the beginning of the study (T=0) and 8 hours after the start of the study (T=8h). Method of measurement: Blood sample.;Lactate level measurement. Timepoint: at the beginning of the study (T=0) and 8 hours after the start of the study (T=8h). Method of measurement: Blood sample.;SVO2 (Mixed venous oxygen saturation). Timepoint: at the beginning of the study (T=0) and 8 hours after the start of the study (T=8h). Method of measurement: Blood sample.;O2ER(Oxygen extraction ratio). Timepoint: at the beginning of the study (T=0) and 8 hours after the start of the study (T=8h). Method of measurement: Blood sample.;CRT(Capillary Refill Time). Timepoint: at the beginning of the study (T=0) and 8 hours after the start of the study (T=8h). Method of measurement: Pressure on the finger for 15 seconds and measuring the capillary return time using a Chronometer.;The total dose of norepinephrine. Timepoint: 8 hours after the start of the study (T=8h). Method of measurement: Use of hemodynamic data recording chart.;The amount of intravenous fluids received. Timepoint: 8 hours after the start of the study (T=8h). Method of measurement: Using intake and output information recording chart.;Urinary output. Timepoint: 8 hours after the start of the study (T=8h). Method of measurement: Using intake and output information recording chart.;Occurrence of dysrhythmias. Timepoint: Whenever it occurs during the study, it will be recorded and checked 8 hours after the start of the study (T=8h). Method of measurement: It will be observed, monitored and recorded by the researcher.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNegin Akbari

Mashhad University of Medical Sciences

AkbariN4022@mums.ac.ir+98 11 4206 1558

Outcome results

None listed

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