Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

Overview

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 Title of Study: “Comparison of Between Norepinephrine Alone Versus Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Study Primary Completion Date: January 5, 2019

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

• 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.

Arms, Groups and Cohorts

• Active Comparator: NE
  • patients received IV Norepinephrine infusion starting with (0.1mcg/kg/min)
• Active Comparator: NE/VP
  • patients received IV Norepinephrine infusion (Starting with (0.1 mcg/kg/min). +Vasopressin infusion at the rate of (0.03 unit/min)

Clinical Trial Outcome Measures

Primary Measures

• Lactate Level Lactate level • (central venous oxygen saturation)SVO2
  • Time Frame: 48 hours
  • mmol/L
• Scvo2
  • Time Frame: 48 hours

Secondary Measures

• NGAL, NGAL NGAL
  • Time Frame: 48 hours
  • ng/ml
• Mortality
  • Time Frame: 28 days
  • 28 days mortality
• CRP
  • Time Frame: 48 hours
  • mg/dl

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Ain Shams University
• Provider of Information About this Clinical Study
  • Principal Investigator: Hanaa Mohamed Abdallah ElGendy MD, Assistant Professor – Ain Shams University