Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

Ain Shams University

Status: Completed

Conditions: Acute Kidney Injury; Septic Shock

Treatments: Drug: norepinephrine / Vasopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT04302584

FMASU MD 239/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups

NE

Active Comparator group

Description:

patients received IV Norepinephrine infusion starting with (0.1mcg/kg/min)

Treatment:

Drug: norepinephrine / Vasopressin

NE/VP

Active Comparator group

Description:

patients received IV Norepinephrine infusion (Starting with (0.1 mcg/kg/min). +Vasopressin infusion at the rate of (0.03 unit/min)

Treatment:

Drug: norepinephrine / Vasopressin