Septic ShockNCT03014063
Vasopressin Plasma Concentrations in Patients Receiving Exogenous Vasopressin Infusion for Septic Shock
An observational study of Septic Shock, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with septic shock that are receiving fixed-dose exogenous vasopressin as an adjunct to catecholamines
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vasopressin Plasma Concentrations in Responders and Non-responders to Exogenous Vasopressin Infusion in Patients With Septic Shock
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.
Read the detailed description
Vasopressin is an endogenous hormone that decreases serum osmolarity and increases blood pressure. As a part of the stress response to hypotension, vasopressin is released from the posterior pituitary and leads to vasoconstriction through agonism of the vascular vasopressin V1 receptor. In patients with septic shock, endogenous vasopressin levels are initially elevated but quickly fall to levels at or below those of normal physiology (1.4-3.6pg/mL) because of the depletion of endogenous store. Sharshar et al. evaluated two sets of patients with septic shock, one of which was evaluated earlier in the septic shock course (3.6 ± 2.3 hours, n=18) and one evaluated at a later time from shock onset (mean 38.7 ± 28.4 hours, n=44). The group of patients evaluated earlier in their septic shock course were more likely than patients evaluated later to have elevated (>3.6 pg/mL) plasma vasopressin levels (88.9% vs. 38.6%, respectively). Similarly, a case series evaluated single vasopressin levels in three patients with septic shock, one of whom was in the first day of shock onset and two of whom were in the fifth and sixth day of shock onset. The patient in the earlier stages of septic shock had a plasma vasopressin level that was increased (16pg/mL), while the two patients in the later stages of septic shock had decreased plasma vasopressin levels (1.6 and 1.8pg/mL). The exact timing of when patients transition from having elevated endogenous vasopressin levels to having normal levels of vasopressin is currently unclear. In a clinical trial enrolling patients within the first 12 hours of shock onset, median endogenous vasopressin levels were 3.5 pg/mL (interquartile range 1.8, 5.3 pg/mL; n=54). Some have even hypothesized that vasopressin levels rise before clinical hypotension is apparent and the decline in vasopressin levels is associated with the onset of apparent hypotension. Further complicating this issue, endogenous vasopressin levels have been shown to be lower in patients with septic shock compared to other shock etiologies such cardiogenic shock (3.1 ± 1pg/mL in patients with septic shock vs. 22.7 ± 2.2pg/mL in patients with cardiogenic shock, p<0.001). The etiology of this discrepancy in endogenous vasopressin response by shock type is unclear, but a "relative deficiency" of vasopressin is theorized to exist in patients with septic shock.
In light of these findings, exogenous arginine vasopressin (AVP) has been added to exogenous catecholamines to increase mean arterial pressure (MAP) and to decrease catecholamine requirements in patients with vasodilatory shock. The use of AVP for these purposes in patients with septic shock is in keeping with the Surviving Sepsis Campaign Guidelines. In the Vasopressin and Septic Shock Trial (VASST), low-dose AVP was infused at a rate of 0.01-0.03 units/min in combination with norepinephrine to achieve a goal MAP of 65-75mmHg. Plasma vasopressin levels in patients receiving AVP were elevated at 6 (68.3pg/mL) and 24 hours (90.5pg/mL) in comparison to patients not receiving AVP (3.0pg/mL at baseline with no significant change at 6 or 24 hours). Association of plasma vasopressin levels with hemodynamic response to AVP, though, was not evaluated in VASST.
Concomitant corticosteroid use has been observed to decrease the total dose of administered AVP, to increase the proportion of patients alive and free of vasopressors at day 7, to increase plasma vasopressin concentrations by 33% at 6 hours and 67% at 24 hours, and to lead to lower 28- and 90-day mortality (35.9% vs. 44.7%, p=0.03 and 42.5% vs. 55.5%, p=0.01, respectively) than in those that received AVP alone. These findings generated the hypothesis that concomitant administration of AVP and corticosteroids results in increased plasma vasopressin levels versus AVP administration alone, leading to positive clinical outcomes in septic shock. Furthering the hypothesis that plasma vasopressin levels may influence outcomes in septic shock, genetic differences in leucyl/cystinyl aminopeptidase, the primary vasopressin metabolic enzyme, have been associated with more rapid vasopressin clearance, lower plasma vasopressin levels, and increased mortality in patients with septic shock. However, a study evaluating vasopressin plasma concentrations in patients with multiple shock types not administered exogenous AVP observed higher vasopressin concentrations in those with hemodynamic dysfunction than in those without (mean 14.1 ± 26 vs. 8.7 ± 10.8pg/mL, respectively) regardless of shock type. This suggests that plasma vasopressin concentration may not directly correlate with MAP.
The impact of body mass (which may influence vasopressin levels when fixed-dose AVP is administered) on hemodynamic response to AVP has been inconsistent. Studies have observed a negative correlation between BMI and change in MAP at 6 hours and a correlation between increasing weight-adjusted AVP dose and reduction in catecholamine requirements, suggesting that hemodynamic response to AVP is associated with body mass. In contrast, a third study observed no association between BMI and AVP dose required to meet goal MAP when AVP was administered as the sole vasopressor. Finally, a fourth found an inverse correlation between BMI and APACHE II-adjusted 28-day mortality, regardless of the fact that overweight and obese patients received less weight-adjusted vasopressin than underweight or normal weight patients. This suggests that while BMI may impact plasma vasopressin concentration, the change in vasopressin concentration may not have an impact on clinical outcomes.
Recently, a retrospective study was completed at the Cleveland Clinic to evaluate predictors of hemodynamic response to fixed-dose AVP in patients with septic shock. Patients were considered to be responders to AVP if a decrease in catecholamine dose was achieved with MAP≥65mmHg at 6 hours. The overall response rate to fixed-dose vasopressin was 45.4%. Within this study, only admission to surgical or neurosciences intensive care units (ICU) vs. medical ICU and lower lactate level were associated with increasing chance of response to AVP (OR 1.71, 95% CI 1.175-2.463, p=0.0049 and OR 0.925, 95% CI 0.887-0.965, p=0.0003, respectively) on logistic regression. Factors previously found to impact vasopressin levels (such as concomitant use of corticosteroids) were not associated with hemodynamic response. However, plasma vasopressin levels were not evaluated in this retrospective study.
The relationship between plasma vasopressin concentration and hemodynamic response in patients receiving AVP is unclear. While concomitant corticosteroids have been observed to increase plasma vasopressin concentrations, corticosteroids themselves have been shown to shorten time in septic shock, possibly confounding any relationship between plasma vasopressin concentration and hemodynamic response in patients receiving both agents. As previously mentioned, data correlating body mass with hemodynamic response have been inconsistent, but vasopressin levels in patients receiving fixed dose AVP seem to be lower in patients with higher body mass. The recent study at the Cleveland Clinic found no association between factors associated with increased plasma vasopressin level and hemodynamic response. Together, these data call into question the idea of a dose-response relationship between plasma vasopressin concentration and hemodynamic response. This study seeks to prospectively evaluate whether plasma vasopressin levels are associated with improved rates of hemodynamic response to fixed-dose AVP therapy in patients with septic shock.
- Conditions
- Septic Shock
- Keywords
- sepsis, septic shock, vasopressin, AVP
- Medical subject headings
- Shock, Septic, Sepsis, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma vasopressin concentration
Measured: 3-6 hours from initiation of exogenous vasopressin administration
Secondary outcomes (7)
Mean arterial pressure
Measured: Analyzed at time of vasopressin blood draw, 3-6 hours from initiation of exogenous vasopressin administration
Catecholamine dose in norepinephrine equivalents
Measured: Analyzed at time of vasopressin blood draw, 3-6 hours from initiation of exogenous vasopressin administration
ICU mortality
Measured: Analyzed at ICU discharge, up to 1 year
In-hospital mortality
Measured: Analyzed at hospital discharge, up to 1 year
Vasopressor-free days
Measured: Day 14
ICU-free days
Measured: Day 14
Acute kidney injury
Measured: Analyzed at ICU discharge, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014063
- Sponsor's protocol ID
- 16-1254
- Status last verified
- Jan 2019
- First submitted
- 4 Jan 2017
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21892977Sharshar 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.
PubMed 12794416Sharshar 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.
PubMed 11990905Bauer 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.
PubMed 20874043Russell 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.
PubMed 18305265Lin 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.
PubMed 16182977Landry 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.
PubMed 9054839Tsuneyoshi 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.
PubMed 11373409Dellinger 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.
PubMed 23353941Gordon 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.
PubMed 24557425Southard 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.
PubMed 20023496Bauer 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.
PubMed 19056013Russell 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.
PubMed 19237882Torgersen 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.
PubMed 21779849Nakada 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.
PubMed 21330387
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressin Plasma Concentrations in Responders and Non-responders to Exogenous Vasopressin Infusion in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT03014063
- Acronym / sponsor ID
- 16-1254
- Conditions
- Septic Shock
- Keywords
- sepsis, septic shock, vasopressin, AVP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vasopressin is an endogenous hormone that decreases serum osmolarity and increases blood pressure. As a part of the stress response to hypotension, vasopressin is released from the posterior pituitary and leads to vasoconstriction through agonism of the vascular vasopressin V1 receptor. In patients with septic shock, endogenous vasopressin levels are initially elevated but quickly fall to levels at or below those of normal physiology (1.4-3.6pg/mL) because of the depletion of endogenous store. Sharshar et al. evaluated two sets of patients with septic shock, one of which was evaluated earlier in the septic shock course (3.6 ± 2.3 hours, n=18) and one evaluated at a later time from shock onset (mean 38.7 ± 28.4 hours, n=44). The group of patients evaluated earlier in their septic shock course were more likely than patients evaluated later to have elevated (>3.6 pg/mL) plasma vasopressin levels (88.9% vs. 38.6%, respectively). Similarly, a case series evaluated single vasopressin levels in three patients with septic shock, one of whom was in the first day of shock onset and two of whom were in the fifth and sixth day of shock onset. The patient in the earlier stages of septic shock had a plasma vasopressin level that was increased (16pg/mL), while the two patients in the later stages of septic shock had decreased plasma vasopressin levels (1.6 and 1.8pg/mL). The exact timing of when patients transition from having elevated endogenous vasopressin levels to having normal levels of vasopressin is currently unclear. In a clinical trial enrolling patients within the first 12 hours of shock onset, median endogenous vasopressin levels were 3.5 pg/mL (interquartile range 1.8, 5.3 pg/mL; n=54). Some have even hypothesized that vasopressin levels rise before clinical hypotension is apparent and the decline in vasopressin levels is associated with the onset of apparent hypotension. Further complicating this issue, endogenous vasopressin levels have been shown to be lower in patients with septic shock compared to other shock etiologies such cardiogenic shock (3.1 ± 1pg/mL in patients with septic shock vs. 22.7 ± 2.2pg/mL in patients with cardiogenic shock, p<0.001). The etiology of this discrepancy in endogenous vasopressin response by shock type is unclear, but a "relative deficiency" of vasopressin is theorized to exist in patients with septic shock.
In light of these findings, exogenous arginine vasopressin (AVP) has been added to exogenous catecholamines to increase mean arterial pressure (MAP) and to decrease catecholamine requirements in patients with vasodilatory shock. The use of AVP for these purposes in patients with septic shock is in keeping with the Surviving Sepsis Campaign Guidelines. In the Vasopressin and Septic Shock Trial (VASST), low-dose AVP was infused at a rate of 0.01-0.03 units/min in combination with norepinephrine to achieve a goal MAP of 65-75mmHg. Plasma vasopressin levels in patients receiving AVP were elevated at 6 (68.3pg/mL) and 24 hours (90.5pg/mL) in comparison to patients not receiving AVP (3.0pg/mL at baseline with no significant change at 6 or 24 hours). Association of plasma vasopressin levels with hemodynamic response to AVP, though, was not evaluated in VASST.
Concomitant corticosteroid use has been observed to decrease the total dose of administered AVP, to increase the proportion of patients alive and free of vasopressors at day 7, to increase plasma vasopressin concentrations by 33% at 6 hours and 67% at 24 hours, and to lead to lower 28- and 90-day mortality (35.9% vs. 44.7%, p=0.03 and 42.5% vs. 55.5%, p=0.01, respectively) than in those that received AVP alone. These findings generated the hypothesis that concomitant administration of AVP and corticosteroids results in increased plasma vasopressin levels versus AVP administration alone, leading to positive clinical outcomes in septic shock. Furthering the hypothesis that plasma vasopressin levels may influence outcomes in septic shock, genetic differences in leucyl/cystinyl aminopeptidase, the primary vasopressin metabolic enzyme, have been associated with more rapid vasopressin clearance, lower plasma vasopressin levels, and increased mortality in patients with septic shock. However, a study evaluating vasopressin plasma concentrations in patients with multiple shock types not administered exogenous AVP observed higher vasopressin concentrations in those with hemodynamic dysfunction than in those without (mean 14.1 ± 26 vs. 8.7 ± 10.8pg/mL, respectively) regardless of shock type. This suggests that plasma vasopressin concentration may not directly correlate with MAP.
The impact of body mass (which may influence vasopressin levels when fixed-dose AVP is administered) on hemodynamic response to AVP has been inconsistent. Studies have observed a negative correlation between BMI and change in MAP at 6 hours and a correlation between increasing weight-adjusted AVP dose and reduction in catecholamine requirements, suggesting that hemodynamic response to AVP is associated with body mass. In contrast, a third study observed no association between BMI and AVP dose required to meet goal MAP when AVP was administered as the sole vasopressor. Finally, a fourth found an inverse correlation between BMI and APACHE II-adjusted 28-day mortality, regardless of the fact that overweight and obese patients received less weight-adjusted vasopressin than underweight or normal weight patients. This suggests that while BMI may impact plasma vasopressin concentration, the change in vasopressin concentration may not have an impact on clinical outcomes.
Recently, a retrospective study was completed at the Cleveland Clinic to evaluate predictors of hemodynamic response to fixed-dose AVP in patients with septic shock. Patients were considered to be responders to AVP if a decrease in catecholamine dose was achieved with MAP≥65mmHg at 6 hours. The overall response rate to fixed-dose vasopressin was 45.4%. Within this study, only admission to surgical or neurosciences intensive care units (ICU) vs. medical ICU and lower lactate level were associated with increasing chance of response to AVP (OR 1.71, 95% CI 1.175-2.463, p=0.0049 and OR 0.925, 95% CI 0.887-0.965, p=0.0003, respectively) on logistic regression. Factors previously found to impact vasopressin levels (such as concomitant use of corticosteroids) were not associated with hemodynamic response. However, plasma vasopressin levels were not evaluated in this retrospective study.
The relationship between plasma vasopressin concentration and hemodynamic response in patients receiving AVP is unclear. While concomitant corticosteroids have been observed to increase plasma vasopressin concentrations, corticosteroids themselves have been shown to shorten time in septic shock, possibly confounding any relationship between plasma vasopressin concentration and hemodynamic response in patients receiving both agents. As previously mentioned, data correlating body mass with hemodynamic response have been inconsistent, but vasopressin levels in patients receiving fixed dose AVP seem to be lower in patients with higher body mass. The recent study at the Cleveland Clinic found no association between factors associated with increased plasma vasopressin level and hemodynamic response. Together, these data call into question the idea of a dose-response relationship between plasma vasopressin concentration and hemodynamic response. This study seeks to prospectively evaluate whether plasma vasopressin levels are associated with improved rates of hemodynamic response to fixed-dose AVP therapy in patients with septic shock.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with septic shock that are receiving fixed-dose exogenous vasopressin as an adjunct to catecholamines
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma vasopressin concentration
Time frame: 3-6 hours from initiation of exogenous vasopressin administration
7 secondary outcomes
Mean arterial pressure
Time frame: Analyzed at time of vasopressin blood draw, 3-6 hours from initiation of exogenous vasopressin administration
Catecholamine dose in norepinephrine equivalents
Time frame: Analyzed at time of vasopressin blood draw, 3-6 hours from initiation of exogenous vasopressin administration
ICU mortality
Time frame: Analyzed at ICU discharge, up to 1 year
In-hospital mortality
Time frame: Analyzed at hospital discharge, up to 1 year
Vasopressor-free days
Time frame: Day 14
ICU-free days
Time frame: Day 14
Acute kidney injury
Time frame: Analyzed at ICU discharge, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Background: PubMed 21892977Russell JA. Bench-to-bedside review: Vasopressin in the management of septic shock. Crit Care. 2011 Aug 11;15(4):226. doi: 10.1186/cc8224.
- Background: PubMed 12794416Sharshar 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.
- Background: PubMed 11990905Sharshar 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.
- Background: PubMed 20874043Bauer 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.
- Background: PubMed 18305265Russell 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.
- Background: PubMed 16182977Lin 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.
- Background: PubMed 9054839Landry 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.
- Background: PubMed 11373409Tsuneyoshi 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.
- Background: PubMed 23353941Dellinger 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.
- Background: PubMed 24557425Gordon 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.
- Background: PubMed 20023496Southard 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.
- Background: PubMed 19056013Bauer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma vasopressin concentration (time frame: 3-6 hours from initiation of exogenous vasopressin administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03014063, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.