Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302584
• Other study ID #: FMASU MD 239/2016
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 6, 2019

Study information

• Verified date: September 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 6, 2019
• Est. primary completion date: January 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Septic Shock
• Shock
• Shock, Septic

Intervention

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.

Locations

Country	Name	City	State
Egypt	Hanaa El Gendy	Cairo	Ain Shams University Specialized Hospital

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactate Level Lactate level • (central venous oxygen saturation)SVO2	mmol/L	48 hours
Primary	Scvo2		48 hours
Secondary	NGAL, NGAL NGAL	ng/ml	48 hours
Secondary	Mortality	28 days mortality	28 days
Secondary	CRP	mg/dl	48 hours