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Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

Primary Purpose

Septic Shock, Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
norepinephrine / Vasopressin
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hanaa El Gendy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

NE

NE/VP

Arm Description

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

patients received IV Norepinephrine infusion (Starting with (0.1 mcg/kg/min). +Vasopressin infusion at the rate of (0.03 unit/min)

Outcomes

Primary Outcome Measures

Lactate Level Lactate level • (central venous oxygen saturation)SVO2
mmol/L
Scvo2

Secondary Outcome Measures

NGAL, NGAL NGAL
ng/ml
Mortality
28 days mortality
CRP
mg/dl

Full Information

First Posted
February 28, 2020
Last Updated
September 4, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04302584
Brief Title
Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock
Official Title
Comparison of Between Norepinephrine Alone Versus Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 5, 2019 (Actual)
Study Completion Date
January 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Acute Kidney Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NE
Arm Type
Active Comparator
Arm Description
patients received IV Norepinephrine infusion starting with (0.1mcg/kg/min)
Arm Title
NE/VP
Arm Type
Active Comparator
Arm Description
patients received IV Norepinephrine infusion (Starting with (0.1 mcg/kg/min). +Vasopressin infusion at the rate of (0.03 unit/min)
Intervention Type
Drug
Intervention Name(s)
norepinephrine / Vasopressin
Other Intervention Name(s)
norepinephrine
Intervention Description
• 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.
Primary Outcome Measure Information:
Title
Lactate Level Lactate level • (central venous oxygen saturation)SVO2
Description
mmol/L
Time Frame
48 hours
Title
Scvo2
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
NGAL, NGAL NGAL
Description
ng/ml
Time Frame
48 hours
Title
Mortality
Description
28 days mortality
Time Frame
28 days
Title
CRP
Description
mg/dl
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Hanaa El Gendy
City
Cairo
State/Province
Ain Shams University Specialized Hospital
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Norepinephrine / Vasopressin Combination for Resuscitation in Septic Shock

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