Vasopressin Plasma Concentrations in Patients Receiving Exogenous Vasopressin Infusion for Septic Shock

NCT03014063 | Completed

• 1 other identifier: 16-1254
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective observational cohort trial evaluating a single plasma vasopressin concentration in patients receiving exogenous, adjunctive vasopressin for septic shock. The trial is designed to determine whether plasma vasopressin concentration influences the likelihood of hemodynamic response to exogenous vasopressin therapy.

Conditions

Septic Shock

Keywords

sepsis; septic shock; vasopressin; AVP

Outcome Measures

Primary Outcomes (1)

• Plasma vasopressin concentration

  3-6 hours from initiation of exogenous vasopressin administration

Secondary Outcomes (7)

• Mean arterial pressure

  Analyzed at time of vasopressin blood draw, 3-6 hours from initiation of exogenous vasopressin administration

• Catecholamine dose in norepinephrine equivalents

  Analyzed at time of vasopressin blood draw, 3-6 hours from initiation of exogenous vasopressin administration

• ICU mortality

  Analyzed at ICU discharge, up to 1 year

• In-hospital mortality

  Analyzed at hospital discharge, up to 1 year

• Vasopressor-free days

  Day 14

Study Arms (2)

Hemodynamic responders

Those with a mean arterial pressure of at least 65mmHg and a decrease in catecholamine dose (in norepinephrine equivalents) from initiation of exogenous vasopressin therapy to the time of the sample collection used for analysis of plasma vasopressin concentration

Hemodynamic non-responders

Those without a mean arterial pressure of at least 65mmHg and/or a decrease in catecholamine dose (in norepinephrine equivalents) from initiation of exogenous vasopressin therapy to the time of the sample collection used for analysis of plasma vasopressin concentration

Eligibility Criteria

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

Study Population

Patients with septic shock that are receiving fixed-dose exogenous vasopressin as an adjunct to catecholamines

You may qualify if:

• Patients with septic shock as defined by The Third International Consensus Definitions for Sepsis and Septic Shock
• Patients ≥18 years of age
• Treatment with exogenous vasopressin, as ordered by the primary medical team, at a constant infusion rate for at least 3 hours as an adjunctive vasopressor to catecholamine therapy
• Admission to a medical, surgical, or neurosciences intensive care unit
• Presence of a central venous catheter or arterial line (as determined by the primary medical team)

You may not qualify if:

• Patients treated with vasopressin for indications other than septic shock
• Patients administered vasopressin that is titrated within the first 3 hours
• Patients receiving vasopressin as the sole vasoactive therapy

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (24)

• Russell JA. Bench-to-bedside review: Vasopressin in the management of septic shock. Crit Care. 2011 Aug 11;15(4):226. doi: 10.1186/cc8224.

  PMID: 21892977 BACKGROUND

• Sharshar T, Blanchard A, Paillard M, Raphael JC, Gajdos P, Annane D. Circulating vasopressin levels in septic shock. Crit Care Med. 2003 Jun;31(6):1752-8. doi: 10.1097/01.CCM.0000063046.82359.4A.

  PMID: 12794416 BACKGROUND

• Sharshar T, Carlier R, Blanchard A, Feydy A, Gray F, Paillard M, Raphael JC, Gajdos P, Annane D. Depletion of neurohypophyseal content of vasopressin in septic shock. Crit Care Med. 2002 Mar;30(3):497-500. doi: 10.1097/00003246-200203000-00001.

  PMID: 11990905 BACKGROUND

• Bauer SR, Lam SW. Arginine vasopressin for the treatment of septic shock in adults. Pharmacotherapy. 2010 Oct;30(10):1057-71. doi: 10.1592/phco.30.10.1057.

  PMID: 20874043 BACKGROUND

• Russell JA, Walley KR, Singer J, Gordon AC, Hebert PC, Cooper DJ, Holmes CL, Mehta S, Granton JT, Storms MM, Cook DJ, Presneill JJ, Ayers D; VASST Investigators. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med. 2008 Feb 28;358(9):877-87. doi: 10.1056/NEJMoa067373.

  PMID: 18305265 BACKGROUND

• Lin IY, Ma HP, Lin AC, Chong CF, Lin CM, Wang TL. Low plasma vasopressin/norepinephrine ratio predicts septic shock. Am J Emerg Med. 2005 Oct;23(6):718-24. doi: 10.1016/j.ajem.2005.02.055.

  PMID: 16182977 BACKGROUND

• Landry DW, Levin HR, Gallant EM, Ashton RC Jr, Seo S, D'Alessandro D, Oz MC, Oliver JA. Vasopressin deficiency contributes to the vasodilation of septic shock. Circulation. 1997 Mar 4;95(5):1122-5. doi: 10.1161/01.cir.95.5.1122.

  PMID: 9054839 BACKGROUND

• Tsuneyoshi I, Yamada H, Kakihana Y, Nakamura M, Nakano Y, Boyle WA 3rd. Hemodynamic and metabolic effects of low-dose vasopressin infusions in vasodilatory septic shock. Crit Care Med. 2001 Mar;29(3):487-93. doi: 10.1097/00003246-200103000-00004.

  PMID: 11373409 BACKGROUND

• 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: 23353941 BACKGROUND

• Gordon AC, Mason AJ, Perkins GD, Stotz M, Terblanche M, Ashby D, Brett SJ. The interaction of vasopressin and corticosteroids in septic shock: a pilot randomized controlled trial. Crit Care Med. 2014 Jun;42(6):1325-33. doi: 10.1097/CCM.0000000000000212.

  PMID: 24557425 BACKGROUND

• Southard RE, Boyle WA. Corticosteroids and the original vasopressin and septic shock trial subgroups. Crit Care Med. 2010 Jan;38(1):338; authore reply 338-9. doi: 10.1097/CCM.0b013e3181bc7ab8. No abstract available.

  PMID: 20023496 BACKGROUND

• Bauer SR, Lam SW, Cha SS, Oyen LJ. Effect of corticosteroids on arginine vasopressin-containing vasopressor therapy for septic shock: a case control study. J Crit Care. 2008 Dec;23(4):500-6. doi: 10.1016/j.jcrc.2008.04.002. Epub 2008 Jun 30.

  PMID: 19056013 BACKGROUND

• Russell JA, Walley KR, Gordon AC, Cooper DJ, Hebert PC, Singer J, Holmes CL, Mehta S, Granton JT, Storms MM, Cook DJ, Presneill JJ; Dieter Ayers for the Vasopressin and Septic Shock Trial Investigators. Interaction of vasopressin infusion, corticosteroid treatment, and mortality of septic shock. Crit Care Med. 2009 Mar;37(3):811-8. doi: 10.1097/CCM.0b013e3181961ace.

  PMID: 19237882 BACKGROUND

• Torgersen C, Luckner G, Schroder DC, Schmittinger CA, Rex C, Ulmer H, Dunser MW. Concomitant arginine-vasopressin and hydrocortisone therapy in severe septic shock: association with mortality. Intensive Care Med. 2011 Sep;37(9):1432-7. doi: 10.1007/s00134-011-2312-3. Epub 2011 Jul 21.

  PMID: 21779849 BACKGROUND

• Nakada TA, Russell JA, Wellman H, Boyd JH, Nakada E, Thain KR, Thair SA, Hirasawa H, Oda S, Walley KR. Leucyl/cystinyl aminopeptidase gene variants in septic shock. Chest. 2011 May;139(5):1042-1049. doi: 10.1378/chest.10-2517. Epub 2011 Feb 17.

  PMID: 21330387 BACKGROUND

• Jochberger S, Mayr VD, Luckner G, Wenzel V, Ulmer H, Schmid S, Knotzer H, Pajk W, Hasibeder W, Friesenecker B, Mayr AJ, Dunser MW. Serum vasopressin concentrations in critically ill patients. Crit Care Med. 2006 Feb;34(2):293-9. doi: 10.1097/01.ccm.0000198528.56397.4f.

  PMID: 16424705 BACKGROUND

• Miller JT, Welage LS, Kraft MD, Alaniz C. Does body weight impact the efficacy of vasopressin therapy in the management of septic shock? J Crit Care. 2012 Jun;27(3):289-93. doi: 10.1016/j.jcrc.2011.06.018. Epub 2011 Aug 19.

  PMID: 21855282 BACKGROUND

• Hodge EK, Hughes DW, Attridge RL. Effect of Body Weight on Hemodynamic Response in Patients Receiving Fixed-Dose Vasopressin for Septic Shock. Ann Pharmacother. 2016 Oct;50(10):816-23. doi: 10.1177/1060028016656384. Epub 2016 Jun 23.

  PMID: 27340145 BACKGROUND

• Lam SW, Bauer SR, Cha SS, Oyen LJ. Lack of an effect of body mass on the hemodynamic response to arginine vasopressin during septic shock. Pharmacotherapy. 2008 May;28(5):591-9. doi: 10.1592/phco.28.5.591.

  PMID: 18447658 BACKGROUND

• Wacharasint P, Boyd JH, Russell JA, Walley KR. One size does not fit all in severe infection: obesity alters outcome, susceptibility, treatment, and inflammatory response. Crit Care. 2013 Jun 20;17(3):R122. doi: 10.1186/cc12794.

  PMID: 23786836 BACKGROUND

• Annane D, Sebille V, Charpentier C, Bollaert PE, Francois B, Korach JM, Capellier G, Cohen Y, Azoulay E, Troche G, Chaumet-Riffaud P, Bellissant E. Effect of treatment with low doses of hydrocortisone and fludrocortisone on mortality in patients with septic shock. JAMA. 2002 Aug 21;288(7):862-71. doi: 10.1001/jama.288.7.862.

  PMID: 12186604 BACKGROUND

• Sprung CL, Annane D, Keh D, Moreno R, Singer M, Freivogel K, Weiss YG, Benbenishty J, Kalenka A, Forst H, Laterre PF, Reinhart K, Cuthbertson BH, Payen D, Briegel J; CORTICUS Study Group. Hydrocortisone therapy for patients with septic shock. N Engl J Med. 2008 Jan 10;358(2):111-24. doi: 10.1056/NEJMoa071366.

  PMID: 18184957 BACKGROUND

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Sacha GL, Lam SW, Duggal A, Torbic H, Bass SN, Welch SC, Butler RS, Bauer SR. Predictors of response to fixed-dose vasopressin in adult patients with septic shock. Ann Intensive Care. 2018 Mar 6;8(1):35. doi: 10.1186/s13613-018-0379-5.

  PMID: 29511951 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma vasopressin concentration in patients receiving exogenous vasopressin

MeSH Terms

Conditions

Shock, Septic; Sepsis; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 9, 2017
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)