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Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

Comparison of Between Norepinephrine Alone Versus Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04302584
Enrollment
90
Registered
2020-03-10
Start date
2018-01-01
Completion date
2019-01-06
Last updated
2020-09-07

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

Conditions

Acute Kidney Injury, Septic Shock

Brief summary

Although norepinephrine is commonly used and is the recommended agent for the treatment of hypotension in volume-resuscitated hyperdynamic septic shock, Low doses of vasopressin may be added to norepinephrine to maintain arterial blood pressure in refractory septic shock and to decrease exposure to norepinephrine. The aim of the work is to compare the effect of norepinephrine alone and Norepinephrine/vasopressin combination on hemodynamics and tissue perfusion in septic shock patients.

Detailed description

Study which was performed on 90 adult of either sex in intensive care unit who developed septic shock.45 patients in each group according to the drugs used, by the single blind technique as the treating physician only is aware of the drugs used. Group 1: patients received IV Norepinephrine infusion starting with (0.1mcg/kg/min). Group 2: patients received IV Norepinephrine infusion (Starting with (0.1 mcg/kg/min). +Vasopressin infusion at the rate of (0.03 unit/min). A comparison was done between both groups as regard:Hemodynamics,Tissue perfusion, C-Reactive Protein (mg/L) ,WBC, UREA (mg/dL),CREATININE (mg/dl), NGAL (Neutrophil gelatinase associated Lipocalin) (ng/ml). Comparison was done at baseline, then every 6 hours for 48 h as regard hemodynamics and tissue perfusion, and at base line then, 24 h and 48 h as regard sepsis biomarkers and renal biomarkers.

Interventions

DRUGnorepinephrine / Vasopressin

• The drug infusion was prepared as 100 IU of AVP (Pressyn; Ferring Inc., Toronto, Ontario, Canada) in 250 ml D5W, infused at the rate of 4.5 ml/h for 0.03 IU/min and 15 mg of Norepinephrine (Arterenol; Sanofi-Aventis, Frankfurt, Germany) in 250 ml D5W infused at the rate of 10 ml/h for 10 mcg/min using infusion pump.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years of both sex

Exclusion criteria

* Patients with renal impairment (Creatinine\>2mg/dl) * Sever Heart Disease (ischemic/valvular) * Peripheral vascular disease (e.g. Raynaud's phenomenon)

Design outcomes

Primary

MeasureTime frameDescription
Lactate Level Lactate level • (central venous oxygen saturation)SVO248 hoursmmol/L
Scvo248 hours

Secondary

MeasureTime frameDescription
NGAL, NGAL NGAL48 hoursng/ml
Mortality28 days28 days mortality
CRP48 hoursmg/dl

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026