Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

NCT04302584 | Completed

• 1 other identifier: FMASU MD 239/2016
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Acute Kidney Injury

Outcome Measures

Primary Outcomes (2)

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

  mmol/L

  48 hours

• Scvo2

  48 hours

Secondary Outcomes (3)

• NGAL, NGAL NGAL

  48 hours

• Mortality

  28 days

• CRP

  48 hours

Study Arms (2)

NE

ACTIVE COMPARATOR

patients received IV Norepinephrine infusion starting with (0.1mcg/kg/min)

Drug: norepinephrine / Vasopressin

NE/VP

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: norepinephrine

NE; NE/VP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years of both sex

You may not qualify if:

• Patients with renal impairment (Creatinine\>2mg/dl)
• Sever Heart Disease (ischemic/valvular)
• Peripheral vascular disease (e.g. Raynaud's phenomenon)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Location

MeSH Terms

Conditions

Shock, Septic; Acute Kidney Injury

Interventions

Norepinephrine; Vasopressins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 10, 2020
• Study Start: January 1, 2018
• Primary Completion: January 5, 2019
• Study Completion: January 6, 2019
• Last Updated: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)