NCT02109965

The Effect of Dexmedetomidine on the Microcirculation in Patients With Severe Sepsis and Septic Shock

Terminated Phase 4 Last updated 28 February 2019

What this trial tests

Phase 4 trial testing Dexmedetomidine in Severe Sepsis in 12 participants. Terminated before completion.

Timeline

1 July 2014

Primary endpoint
24 February 2016

24 February 2018

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	12
Start date	1 July 2014
Primary completion	24 February 2016
Estimated completion	24 February 2018
Sites	1 location across Taiwan

Drugs / interventions tested

• Dexmedetomidine (dexmedetomidine) — full drug profile →
• Midazolam (midazolam) — full drug profile →
• Propofol (Propofol) — full drug profile →

Conditions studied

• Severe Sepsis — all drugs for Severe Sepsis →

Sponsor

National Taiwan University Hospital

Who can join

20 and older, any sex, with Severe Sepsis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Changes of total small vessel density and perfused small vessel density
  Time frame: 6h

Sponsor's own description

Despite early goal-directed maintenance of normal macrocirculation, the reduction of 60-day mortality of patients with severe sepsis and septic shock remained unsatisfied (56.9% to 44.3%). One of the major causes of high mortality is microcirculatory dysfunction. Delayed diagnosis and treatment of microcirculatory dysfunction may cause tissue hypoperfusion and resulted in multiple organ dysfunction and death. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist which exhibits sedative and analgesic effects. Recent studies suggest that dexmedetomidine also has anti-coagulation and anti-inflammatory effects, and it can reduce the mortality of endotoxemic rats and patients with severe sepsis. The investigators will conduct two animal studies and one clinical trial to investigate the effect of dexmedetomidine on microcirculatory dysfunction and organ injury in rat with endotoxemia and patients with severe sepsis and septic shock.

Sixty patients with severe sepsis and septic shock will be enrolled and randomized to control group or dexmedetomidine group. In the control group, the patients will be treated according to the clinical practice guideline. If sedation is required, non-dexmedetomidine sedative agents will be used. In the dexmedetomidine group, the patients will be treated according to the clinical practice guideline, and they will also receive continuous infusion of dexmedetomidine (infusion rate ranged from 0.1 to 0.7 mcg/kg/h) for 24 hours as needed. The sublingual microcirculation, serum level of Endocan, NGAL(Neutrophil Gelatinase-Associated Lipocalin), and BNP(B-type natriuretic peptide) will be examined at preset time points up to 24 hours. The vital signs, hemodynamic parameters, and survival of 28-day and 90-day will be recorded and analyzed.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Emerging therapeutic targets of sepsis-associated acute kidney injury.
   Swaminathan S, Rosner MH, Okusa MD. · · 2015 · cited 29× · PMID 25795498 · DOI 10.1016/j.semnephrol.2015.01.005