Terlipressin in Septic Shock: Effects on Microcirculation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Septic Shock Sepsis |
Drug: continuous infusion of terlipressin Drug: Arginine vasopressin Drug: terlipressin bolus administration |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Vasopressin Receptor Agonists in Septic Shock: Effects on Microcirculation |
- 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 ]
- 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 ]
| Enrollment: | 60 |
| Study Start Date: | November 2008 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: continuous terlipressin |
Drug: continuous infusion of terlipressin
Intravenous continuous infusion of terlipressin 1 µg•kg-1•h-1 for 6 hrs
|
| Experimental: vasopressin |
Drug: Arginine vasopressin
Intravenous continuous infusion of arginine vasopressin 0.04 UI•min-1 for 6 hrs
|
| Experimental: terlipressin bolus dose |
Drug: terlipressin bolus administration
intravenous terlipressin bolus administration at the dose of 0.5 mg
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| Italy | |
| Departement of Anesthesiology and Intensive Care | |
| Rome, I, Italy, 00161 | |
| Principal Investigator: | Andrea Morelli, MD | University of Rome "La Sapienza", Department of Anesthesiology and Intensive Care |
More Information
No publications provided by University of Roma La Sapienza
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Andrea Morelli, University of Rome "La Sapienza" |
| ClinicalTrials.gov Identifier: | NCT00995839 History of Changes |
| Other Study ID Numbers: | 1065 |
| Study First Received: | October 14, 2009 |
| Last Updated: | February 3, 2010 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Roma La Sapienza:
|
terlipressin vasopressin sepsis septic shock norepinephrine |
Additional relevant MeSH terms:
|
Sepsis Shock Shock, Septic Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Arginine Vasopressin Vasopressins Lypressin Terlipressin |
Hemostatics Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs Antihypertensive Agents |
ClinicalTrials.gov processed this record on June 17, 2013