Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

Not Applicable

Completed

• Conditions: Septic Shock; Acute Kidney Injury
• Interventions: Drug: norepinephrine / Vasopressin

• Registration Number: NCT04302584
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-01-05
• Study Completion: 2019-01-06
• Study First Submitted: 2020-02-28
• Study First Submitted QC: 2020-03-08
• Study First Posted: 2020-03-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NE	norepinephrine / Vasopressin	patients received IV Norepinephrine infusion starting with (0.1mcg/kg/min)
NE/VP	norepinephrine / Vasopressin	patients received IV Norepinephrine infusion (Starting with (0.1 mcg/kg/min). +Vasopressin infusion at the rate of (0.03 unit/min)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mortality	28 days	28 days mortality
CRP	48 hours	mg/dl
NGAL, NGAL NGAL	48 hours	ng/ml

Trial Locations

Locations (1)

Hanaa El Gendy; 🇪🇬 Cairo, Ain Shams University Specialized Hospital, Egypt