Septic ShockPhase 3NCT03038503
What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin
A Phase 3 study testing Methylene Blue and Terlipressin in people with Septic Shock and Refractory Shock, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6 hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Septic Shock, Refractory Shock
- What is being tested?
- Methylene Blue and Terlipressin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2016to Dec 2018
- Phase
- Phase 3
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age >15 years old
- Diagnosis septic shock as SCCM/ACCP
- Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE >0.5 mcg/kg/min)
- Concent form
Who cannot join
- Known case G6PD deficiency
- Acute respiratory distress syndrome (ARDS)
- Hx of drug allergy MB, NE, terlipressin
- Hx of Raynaud's phenomenon, systemic sclerosis, PHT
- Known case coronary heart disease without treatment
- Current drug use serotonin reuptake inhibitors (SSRI), Serotonin and norepinephrine reuptake inhibitors (SNRIs)
- Reject to join project
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Ramathibodi hospital
Bangkok, 066
munthana sundusadee, md, 66639010178, opal_janeway@hotmail.com
About this study
Official title: What Should be the Next Vasopressor for Severe Septic Shock Patients? Methylene Blue or Terlipressin
The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6 hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock with catecholamine resistance has been studied such as terlipressin, methylene blue
- Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C, and increases intracellular Ca2+ concentration
- Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme guanylate cyclase (GC)
- Conditions
- Septic Shock, Refractory Shock
- Being tested
- Methylene Blue, Terlipressin
- Keywords
- refractory septic shock, catecholamine resistance septic shock, terlipressin, methylene blue
- Medical subject headings
- Shock, Septic, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
after defined refractory shock (need NE>0.5 mcg/kg/min) add Methylene blue 1 mg/kg iv drip then 2 hr later drip 0.5 mg/kg/hr*4 hr (intervention add on to standard care)
TerlipressinDrug
after defined refractory shock (need NE>0.5 mcg/kg/min) add terlipressin 1 mg IV then repeated dose 20 min later if unstable BP (intervention add on to standard care)
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | standard care septic shock according sepsis bundles |
| B | Experimental | after defined refractory shock (adequate fluid resuscitation + add NE>0.5 mcg/kg/min) add Methylene blue 1 mg/kg iv drip then 2 hr later drip 0.5 mg/kg/hr*4 hr (intervention add on to standard care) Receives: Drug: Methylene Blue |
| C | Experimental | after defined refractory shock (adequate fluid resuscitation + add NE>0.5 mcg/kg/min) add terlipressin 1 mg IV then repeated dose 20 min later if unstable BP (intervention add on to standard care) Receives: Drug: Terlipressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
Measured: 7 days
time to wean of vasopressor
Measured: through complete weaning off vasopressor, an average of 24 hours
ICU duration
Measured: through out off indication need ICU care, an average of 7 days
Secondary outcomes (3)
hemodynamic parameter: Mean arterial pressure (mmHg)
mmHg, A-line monitoring
Measured: every 30 min after start protocol up to 6 hr then every 1 hr up to 24 hours
hemodynamic parameter: lactate (mmol/l)
mmol/l
Measured: every 2 hr until 6 hr then every 4 hr until wean off vasopressor up to 24 hours
hemodynamic parameter: urine output (ml)
ml
Measured: every 2 hr until wean off vasopressor up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, munthana sundusadee, Ramathibodi Hospital
- Investigators
- viratch tangsujaritvijit, MD, Study chair, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038503
- Sponsor's protocol ID
- ID 09-59-14
- Status last verified
- Aug 2018
- First submitted
- 22 Dec 2016
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Should be the Next Vasopressor for Severe Septic Shock Patients? Methylene Blue or Terlipressin
- ClinicalTrials.gov ID
- NCT03038503
- Acronym / sponsor ID
- ID 09-59-14
- Conditions
- Septic Shock, Refractory Shock
- Keywords
- refractory septic shock, catecholamine resistance septic shock, terlipressin, methylene blue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 31 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.
The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6 hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock with catecholamine resistance has been studied such as terlipressin, methylene blue
- Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C, and increases intracellular Ca2+ concentration
- Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme guanylate cyclase (GC)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –standard care septic shock according sepsis bundles |
| B | Experimental | Drug: Methylene Blueafter defined refractory shock (adequate fluid resuscitation + add NE>0.5 mcg/kg/min) add Methylene blue 1 mg/kg iv drip then 2 hr later drip 0.5 mg/kg/hr*4 hr (intervention add on to standard care) |
| C | Experimental | Drug: Terlipressinafter defined refractory shock (adequate fluid resuscitation + add NE>0.5 mcg/kg/min) add terlipressin 1 mg IV then repeated dose 20 min later if unstable BP (intervention add on to standard care) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age >15 years old
- Diagnosis septic shock as SCCM/ACCP
- Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE >0.5 mcg/kg/min)
- Concent form
Key exclusion criteria (7 listed)
- Known case G6PD deficiency
- Acute respiratory distress syndrome (ARDS)
- Hx of drug allergy MB, NE, terlipressin
- Hx of Raynaud's phenomenon, systemic sclerosis, PHT
- Known case coronary heart disease without treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene Blueafter defined refractory shock (need NE>0.5 mcg/kg/min) add Methylene blue 1 mg/kg iv drip then 2 hr later drip 0.5 mg/kg/hr*4 hr (intervention add on to standard care) | Drug | B |
| Terlipressinafter defined refractory shock (need NE>0.5 mcg/kg/min) add terlipressin 1 mg IV then repeated dose 20 min later if unstable BP (intervention add on to standard care) | Drug | C |
Primary outcome
mortality rate
Time frame: 7 days
time to wean of vasopressor
Time frame: through complete weaning off vasopressor, an average of 24 hours
ICU duration
Time frame: through out off indication need ICU care, an average of 7 days
3 secondary outcomes
hemodynamic parameter: Mean arterial pressure (mmHg)
Time frame: every 30 min after start protocol up to 6 hr then every 1 hr up to 24 hours
hemodynamic parameter: lactate (mmol/l)
Time frame: every 2 hr until 6 hr then every 4 hr until wean off vasopressor up to 24 hours
hemodynamic parameter: urine output (ml)
Time frame: every 2 hr until wean off vasopressor up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- 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.
viratch tangsujaritvijit, MD study chair
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylene Blue and Terlipressin in people with Septic Shock and Refractory Shock, run by Ramathibodi Hospital at 1 site in Thailand.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Aug 2018. 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 Thailand. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact munthana sundusadee, MD (66639010178, opal_janeway@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2018.