Terlipressin in Septic Shock: Effects on Microcirculation

This study has been completed.
Sponsor:
Information provided by:
University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT00995839
First received: October 14, 2009
Last updated: February 3, 2010
Last verified: October 2009

October 14, 2009
February 3, 2010
November 2008
February 2010   (final data collection date for primary outcome measure)
  • Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI) [ Time Frame: over a period of 6 hrs from the time of randomization ] [ Designated as safety issue: No ]
  • Oxygen transport variables [ Time Frame: over a period of 6 from the time of randomization ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00995839 on ClinicalTrials.gov Archive Site
  • Acid-base homeostasis [ Time Frame: over a period of 6 hrs from the time of randomization ] [ Designated as safety issue: No ]
  • Functional capillary density (mm/mm2) (FCD) [ Time Frame: over a period of 6 hrs from the time of randomization ] [ Designated as safety issue: No ]
  • De Backer score [ Time Frame: over a period of 6 hrs from the time of randomization ] [ Designated as safety issue: No ]
  • Perfused Vessel Density (PVD) (mm/mm2) [ Time Frame: over a period of 6 hrs from the time of randomization ] [ Designated as safety issue: No ]
  • Proportion of Perfused vessels (%) (PPV) [ Time Frame: over a period of 6 hrs from the time of randomization ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Terlipressin in Septic Shock: Effects on Microcirculation
Vasopressin Receptor Agonists in Septic Shock: Effects on Microcirculation

The present study was conducted as a prospective, randomized study to investigate the effects of vasopressin receptor agonists terlipressin and vasopressin on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock.

60 septic shock patients requiring norepinephrine to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study. After an initial hemodynamic resuscitation aimed at achieve a mean arterial pressure between 65 and 75 mmHg and normovolemia, patients will be randomly allocated to be treated with either a) intravenous administration of terlipressin 1 µg∙kg-1∙h-1 for 6 hrs, b) intravenous administration of arginine vasopressin 0.04 UI∙min-1 for 6 hrs, c) intravenous administration of terlipressin bolus dose of 0.5 mg (each n = 20). In all groups open label norepinephrine will be additionally administered to maintain a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary. Data from right heart catheterization and sublingual microvascular network will be obtained just before randomization (baseline) and then after 6 hours in the vasopressin, terlipressin infusion and terlipressin bolus groups.

The sublingual microvascular network will be studied using the sidestream dark field (SDF)imaging. The device will be applied on the lateral side of the tongue, in an area approximately 2-4 cm from the tip of the tongue. Sequences of 10 secs from eight adjacent areas will be recorded on disk using a personal computer. These sequences will be later analyzed by an investigator blinded to the patient's diagnosis and therapy.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Septic Shock
  • Sepsis
  • Drug: continuous infusion of terlipressin
    Intravenous continuous infusion of terlipressin 1 µg•kg-1•h-1 for 6 hrs
  • Drug: Arginine vasopressin
    Intravenous continuous infusion of arginine vasopressin 0.04 UI•min-1 for 6 hrs
  • Drug: terlipressin bolus administration
    intravenous terlipressin bolus administration at the dose of 0.5 mg
  • Experimental: continuous terlipressin
    Intervention: Drug: continuous infusion of terlipressin
  • Experimental: vasopressin
    Intervention: Drug: Arginine vasopressin
  • Experimental: terlipressin bolus dose
    Intervention: Drug: terlipressin bolus administration
Morelli A, Donati A, Ertmer C, Rehberg S, Kampmeier T, Orecchioni A, Di Russo A, D'Egidio A, Landoni G, Lombrano MR, Botticelli L, Valentini A, Zangrillo A, Pietropaoli P, Westphal M. Effects of vasopressinergic receptor agonists on sublingual microcirculation in norepinephrine-dependent septic shock. Crit Care. 2011;15(5):R217. doi: 10.1186/cc10453. Epub 2011 Sep 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of septic shock
  • Vasopressor support to maintain mean arterial pressure (MAP) between 65 and 75 mmHg despite adequate volume resuscitation (pulmonary artery occlusion pressure = 13-18 mmHg and central venous pressure = 8-12 mmHg)

Exclusion Criteria:

  • Pregnancy
  • Age < 18 years
  • Present or suspected acute mesenteric ischemia
  • Vasospastic diathesis (e.g. Raynaud's syndrome or related diseases)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00995839
1065
No
Andrea Morelli, University of Rome "La Sapienza"
University of Roma La Sapienza
Not Provided
Principal Investigator: Andrea Morelli, MD University of Rome "La Sapienza", Department of Anesthesiology and Intensive Care
University of Roma La Sapienza
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP