NCT01945983

Brief Summary

Current septic shock guideline recommends fluid resuscitation as the first treatment. Vasopressors, including norepinephrine is recommended to start after achieve adequate fluid therapy. This can cause a certain duration of systemic hypotension before vasopressor is commenced. Initiation of norepinephrine together with fluid therapy soon after diagnosis of septic shock may increase blood pressure quicker than start treatment with intravenous fluid alone. The rapid restoration of perfusion pressure may improve septic shock outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2013

Completed
14 days until next milestone

Study Start

First participant enrolled

October 3, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

September 16, 2013

Last Update Submit

January 8, 2018

Conditions

Septic ShockSevere Sepsis

Keywords

Septic shockSevere sepsisNorepinephrine

Outcome Measures

Primary Outcomes (1)

  • Therapeutic goal achievement

    Therapeutic goal including 1. Mean arterial blood pressure \> or = 65 mmHg 2. Evidence of adequate tissue perfusion which include continuation of urine output \> or = 0.5 ml/kg/hour for 2 hours or decreasing of serum lactate \> or = 10 percent in 1 to 2 hours.

    6 hours

Secondary Outcomes (1)

  • Mortality rate

    28 days

Other Outcomes (1)

  • Survive with organ support free days

    28 days

Study Arms (2)

Early norepinephrine

ACTIVE COMPARATOR

Norepinephrine 4 mg in 5% dextrose water 250 ml Intravenous infusion rate range from 8 to 15 ml/hour, adjusted according to patient's body weight to achieve norepinephrine 0.05microgram/kg/min Continuous drip for 48 hours.

Drug: Early norepinephrine

Placebo

PLACEBO COMPARATOR

5% dextrose water 250 ml Intravenous infusion rate range from 8 to 15 ml/hour. Adjust rate of infusion according to patient's body weight to achieve dosage of norepinephrine comparable to 0.05 microgram/kg/min Continuous drip for 48 hours.

Drug: Placebo

Interventions

Early norepinephrineDRUG

Initiation of norepinephrine, a strong vasoconstrictor, at the initiation of septic shock management, together with fluid resuscitation.

Also known as: Early vasopressor therapy
Early norepinephrine
PlaceboDRUG

5% dextrose water intravenous drip in the same rate of calculated norepinephrine for the patient's body weight

Also known as: 5%D/W infusion as the placebo of norepinephrine.
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> or = 18 years old
  • Diagnosed severe sepsis or septic shock according to survival sepsis campaign 2013
  • Mean arterial pressure \< 65 mmHg

You may not qualify if:

  • Pregnancy
  • Severe underlying condition that unexpected to survive more than 48 hours
  • Severe peripheral vascular disease
  • Patient who required major surgery within 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Related Publications (2)

  • Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.

    PMID: 23353941RESULT

  • Permpikul C, Tongyoo S, Viarasilpa T, Trainarongsakul T, Chakorn T, Udompanturak S. Early Use of Norepinephrine in Septic Shock Resuscitation (CENSER). A Randomized Trial. Am J Respir Crit Care Med. 2019 May 1;199(9):1097-1105. doi: 10.1164/rccm.201806-1034OC.

    PMID: 30704260DERIVED

MeSH Terms

Conditions

Shock, SepticSepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Chairat Permpikul, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2013

First Posted

September 19, 2013

Study Start

October 3, 2013

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

TH(1)