An interventional study of norepinephrine / Vasopressin in Septic Shock and Acute Kidney Injury, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-07.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 90 is above the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria
patients received IV Norepinephrine infusion starting with (0.1mcg/kg/min)
Drug: norepinephrine / Vasopressin
patients received IV Norepinephrine infusion (Starting with (0.1 mcg/kg/min). +Vasopressin infusion at the rate of (0.03 unit/min)
Drug: norepinephrine / 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.
Also known as: norepinephrine
Lactate Level Lactate level • (central venous oxygen saturation)SVO2
mmol/L
Time frame: 48 hours
Scvo2
Time frame: 48 hours
NGAL, NGAL NGAL
ng/ml
Time frame: 48 hours
Mortality
28 days mortality
Time frame: 28 days
CRP
mg/dl
Time frame: 48 hours
Plan to share: No
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Ain Shams University