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Completed

NCT Number: NCT04302584

Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

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.

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Key information

Conditions

Septic Shock Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

norepinephrine / Vasopressin

Drug
  • 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.

Other names: norepinephrine

Primary outcomes

  1. Lactate Level Lactate level • (central venous oxygen saturation)SVO2

    Time frame: 48 hours

    mmol/L

  2. Scvo2

    Time frame: 48 hours

Secondary outcomes

  1. NGAL, NGAL NGAL

    Time frame: 48 hours

    ng/ml

  2. Mortality

    Time frame: 28 days

    28 days mortality

  3. CRP

    Time frame: 48 hours

    mg/dl

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2020
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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