Upregulation of Alpha-1 Receptors Upon Septic Shock?

NCT01856517 | Terminated Phase 2 DMC

• 1 other identifier: 2011PPRC01TURC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The hallmarks of septic shock are hypovolemia and reduced pressor response to endogenous noradrenaline. The working hypothesis is that the higher the plasma concentration of endogenous noradrenaline will be, the lower the pressor response to exogenous noradrenaline will be. This will be tested in patients presenting with septic shock, following state of the art management (including repeated assessment of vena cava diameter and compliance, and response to dynamic indices of loading) following placebo vs clonidine administration (1 mcg.kg-1.h-1 over 24 h without bolus) and administration of increasing doses of noradrenaline (1 mcg, 2 mcg, etc. up to a delta systolic blood pressure circa 25-30 mm Hg).

Conditions

Septic Shock

Keywords

pressor response; chronotropic response

Outcome Measures

Primary Outcomes (1)

• change in pressor response to exogenous noradrenaline

  bolus of exogenous noradrenaline (1 mcg and up) are administered to the patient to evoke an increase in delta systolic blood pressure by 25-30 mm Hg. Administration of increasing dose of noradrenaline is stopped as soon as delta systolic blood pressure has reached 25-30 mm Hg.

  0 and 24 h

Secondary Outcomes (1)

• change in heart rate response to increasing doses of dobutamine (100 mcg and up) to evoke an increase in heart rate up to 20 beats per min.

  0 and 24 h

Study Arms (2)

placebo

PLACEBO COMPARATOR

saline administration over 24 h following full optimization of patient according to current guidelines

Drug: Placebo

clonidine

ACTIVE COMPARATOR

clonidine 1 mcg.kg-1.h-1 over 24 h following full optimization of the patient according to current guidelines

Drug: Clonidine

Interventions

Clonidine DRUG

clonidine

Placebo DRUG

placebo

Eligibility Criteria

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

You may qualify if:

• criteria for sepsis :temperature\>38.5 or \<36°C ; WBC\>12 000 or \<4000/ml ; tachypnea (\>20 cycles par min) or mechanical ventilation ; tachycardia : \>90 bpmin

You may not qualify if:

• age\<18 ans
• pregnancy
• mental illness making informed consent impossible
• individual without social security coverage or participating in another biomedical research
• Contre-indications to clonidine (uncorrected hypovolemia, sick sinus syndrom, III grade AV block)
• HR\<70 bp/min
• pre-exitus

Sponsors & Collaborators

• Direction Centrale du Service de Santé des Armées: lead

Study Sites (1)

Critical Care Unit, Hopital Desgenettes

Lyon, 69275, France

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD attending physician

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: May 17, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2014
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

FR (1)