SepsisMtiSSNCT03748537
Mitochondrial Function in Septic Patients
A study testing Hydrocortisone in people with Sepsis and Septic Shock, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Aim #1 To investigate the prevalence, risk and correlation of the level of sepsis with mitochondrial dysfunction in sepsis patients Aim 1.1 To investigate the prevalence of mitochondria dysfunction among sepsis patients Aim 1.2 To investigate the risk associated with mitochondrial dysfunction in sepsis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Interventional
- 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
Who may be able to join
- Adults (≥18 years of age)
- Diagnosis of sepsis within 1 hour after presentation to the emergency department: known or presumed infection and SOFA score > 2 (table1)
- Norepinephrine-resistant hypotension (refractory hypotension and not response to norepinephrine dose ≥ 0.5 mcg/k/min)
Who cannot join
- Known pregnancy
- Primary diagnosis of:
- acute cerebral vascular event
- acute coronary syndrome
- acute cardiogenic pulmonary edema
- status asthmaticus
Show all 23Show fewer
- major cardiac arrhythmia (as part of primary diagnosis)
- seizure
- drug overdose
- injury from burn or trauma
- Hemodynamic instability due to active hemorrhage
- Requirement for immediate surgery
- Do-Not-Attempt-Resuscitation (DNAR) order
- Advanced directives restricting implementation of the resuscitation protocol
- Transferred from another in-hospital setting
- Sepsis or septic shock is not final diagnosis
- Known history of HIV infection with suspected or known Cluster of differentiation 4 (CD4) <100 /mm2
- Contraindication to central venous catheterization
- Contraindication to blood transfusion
- Attending clinician deems aggressive resuscitation unsuitable
- Known history of HIV infection with suspected or known CD4 <100 /mm2
- Neurodegenerative disease (effected mitochondria function)
- known case adrenal insufficiency or chronic steroid user (Patient in this group should receive Hydrocortisone)
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Emergency Department, Faculty of Medicine, Chaing Mai University
Chiang Mai, 50200
About this study
Aim #1 To investigate the prevalence, risk and correlation of the level of sepsis with mitochondrial dysfunction in sepsis patients Aim 1.1 To investigate the prevalence of mitochondria dysfunction among sepsis patients Aim 1.2 To investigate the risk associated with mitochondrial dysfunction in sepsis patients.
Aim 1.3 To investigate the association between sepsis severity (SOFA scoring system) and the degree of mitochondrial dysfunction Aim #2 To investigate the association of mitochondrial dysfunction in sepsis with ScvO2, lactate and ∆PCO2 Aim 3.1 To investigate the therapeutic efficacy of steroids on the improvement mitochondrial function in sepsis patients Aim 3.2. To investigate the efficacy of steroids on the reduction mortality rate in sepsis patients with norepinephrine-resistant hypotension
Read the detailed description
Aim #1 To investigate the prevalence, risk and correlation of the level of sepsis with mitochondrial dysfunction in sepsis patients Aim 1.1 To investigate the prevalence of mitochondria dysfunction among sepsis patients Hypothesis: Most of sepsis patients are affected by mitochondria dysfunction. Since there are many suspected cases of sepsis in the emergency department, mitochondrial function measurements will be collected. After the patients are diagnosed, the degree of mitochondrial function will be reported as a percent among all of sepsis patients.
Aim 1.2 To investigate the risk associated with mitochondrial dysfunction in sepsis patients.
Hypothesis: Some risks other than infection are associated with mitochondrial dysfunction in septic patient.
Since there are many suspected cases of sepsis in the emergency department, mitochondrial function measurements will be collected. After the patients are diagnosed, the degree of mitochondrial function will be reported at intervals. Additionally, the correlation among sex, age, obesity, underlying symptoms, cause of infection, pathogen, onset of fever before emergency department visit, number of organ dysfunction, presence of shock and other hemodynamic parameter will be collected.
Aim 1.3 To investigate the association between sepsis severity (SOFA scoring system) and the degree of mitochondrial dysfunction Hypothesis: The severity of sepsis and organ dysfunction are associated with the severity of mitochondrial dysfunction.
Since there are many suspected cases of sepsis in the emergency department, mitochondrial function measurements will be collected. After the patients are diagnosed, the degree of mitochondrial function will be reported at intervals along with the correlation with the severity of sepsis in SOFA scoring system.
Aim #2 To investigate the association of mitochondrial dysfunction in sepsis with ScvO2, lactate and ∆PCO2 Hypothesis: Persistence of high lactate and extreme change of ScvO2 or ∆PCO2 after sepsis bundle care are associated with severity of mitochondrial dysfunction.
Since patients are suspected of having sepsis with hypoperfusion (1. Blood lactate > 4 mmol/L, 2. Refractory hypotension: after bolus fluid 20 mL/kg and Systolic Blood Pressure still < 90 mmHg or require vasopressor), the sepsis bundle care will be started in the emergency department. The goals of this treatment are 1. A mean arterial pressure of > 65 is achieved by fluid resuscitation and vasopressor, 2. Lactate > 4 mmol/L or ScvO2 > 70 is achieved. After 6 hours following the beginning of resuscitation, blood examination for mitochondrial function, ScvO2 and ∆PCO2 will be determined. The correlation between these physiologic/biomarkers and mitochondrial function will be evaluated.
Aim #3 To investigate the roles of steroid administration on mitochondrial function in sepsis patients (Therapeutic trial) Aim 3.1 To investigate the therapeutic efficacy of steroids on the improvement mitochondrial function in sepsis patients Hypothesis: Steroids administration improve mitochondrial function in norepinephrine-resistant sepsis.
After resuscitation, hypoperfusion in the sepsis patients will be treated by fluid resuscitation and vasopressor. Some groups of patients may be not responsive to this treatment (MAP <65 mmHg), administration of steroids to this group will be blindly randomized (treatment and control group). During resuscitation of septic shock patients with fluid resuscitation and vasopressors, some may not respond to treatment (MAP < 65 mmHg). Patients who have shock refractory to fluid resuscitation and norepinephrine therapy for more than 0.5 mcg/kg/min will be blindly randomized to receive steroid (treatment group) or placebo (control group). Blood samples will be obtained to determine mitochondrial functioning before, at day 1 and day 7 after administration of study medications in both groups.
Aim 3.2. To investigate the efficacy of steroids on the reduction mortality rate in sepsis patients with norepinephrine-resistant hypotension Hypothesis: Steroids improve survival in septic shock patients with norepinephrine-resistant hypotension.
During resuscitation of septic shock patients with fluid resuscitation and vasopressors, some may not respond to treatment (MAP < 65 mmHg). Patients who have shock refractory to fluid resuscitation and norepinephrine administration more than 0.5 mcg/kg/min will be blindly randomized to receive steroid (treatment group) or placebo (control group). Blood samples will be obtained to determine mitochondrial functioning before, at day 1 and day 7 after administration of study medications in both groups. Thirty-day survival will be analyzed by a survival analysis.
- Conditions
- Sepsis, Septic Shock
- Being tested
- Hydrocortisone
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Also called Cortisol
After resuscitation, hypoperfusion in the sepsis patients will be treated by fluid resuscitation and vasopressor. Some groups of patients may be not responsive to this treatment (MAP <65 mmHg), administration of steroids to this group will be blindly randomized (treatment and control group). During resuscitation of septic shock patients with fluid resuscitation and vasopressors, some may not respond to treatment (MAP < 65 mmHg). Patients who have shock refractory to fluid resuscitation and norepinephrine therapy for more than 0.5 mcg/kg/min will be blindly randomized to receive steroid (treatment group) or placebo (control group). Blood samples will be obtained to determine mitochondrial functioning before, at day 1 and day 7 after administration of study medications in both groups.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone | Experimental | Hydrocortisone will be administered intravenously at 200 mg every 24 hours for 5 days, then tapered to a 50 mg intravenous bolus every 12 hours for days 6 to 8 and 50 mg every 24 hours for days 9 to 11, and then stopped. Receives: Drug: Hydrocortisone |
| No Hydrocortisone | No intervention | In control group, patient will not receive any corticosteroids for seven day after inclusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the level of mitochondrial respiration after steroid administration
Mean level comparative of mitochondrial respiration* in "Hydrocortisone" and "No intervention" groups will be investigated at before, day 1 after and day 7 after administration of intervention.
*Mitochondrial function are mitochondrial respiration (Oxygen consumption rate in basal respiration, adenosine triphosphate (ATP) production, maximal respiration, spare capacity, proton leak, and non-mitochondrial respiration; Report in picomole/min)
Measured: 7 days
To investigate the level of mitochondrial stress after steroid administration
Mean level comparative of mitochondrial stress* in "Hydrocortisone" and "No intervention" groups will be investigated at before, day 1 after and day 7 after administration of intervention.
*Mitochondrial stress (mass of superoxide per mitochondrial mass) and oxidative phosphorylation in each complex (densitometric analysis by western blot)
Measured: 7 days
To evaluate survival in septic patients who have refractory shock after steroid administration
Evaluate survival comparison in "Hydrocortisone" and "No intervention" groups. In 28 days survival and survival analysis until 28 day.
Measured: 28 days
Secondary outcomes (5)
To investigate risk factor (Age, underlying disease, number of organ dysfunction) correlation with the mitochondrial function in sepsis patients
Since there are many suspected cases of sepsis in the emergency department, mitochondrial function* measurements will be collected. Additionally, the correlation among sex, age, obesity, underlying symptoms, cause of infection, pathogen, onset of fever before emergency department (ED) visit. Correlation between mitochondrial function and each factor will be compare in percent, mean or median in each group.
*Mitochondrial function are mitochondrial respiration (Oxygen consumption rate in basal respiration, ATP production, maximal respiration, spare capacity, proton leak, and non-mitochondrial respiration), mitochondrial stress (mass of superoxide per mitochondrial mass) and oxidative phosphorylation in each complex (densitometric analysis by western blot)
Measured: since emergency department admission until blood examination was collected, up to 24 hours.
To investigate severity level of sepsis (SOFA Score) correlation with the mitochondrial function in sepsis patients
Since there are many suspected cases of sepsis in the emergency department, mitochondrial function* measurements will be collected. SOFA score**when patient visiting ED. Correlation between mitochondrial function and SOFA score present in linear correlation.
*Mitochondrial function are mitochondrial respiration (Oxygen consumption rate in basal respiration, ATP production, maximal respiration, spare capacity, proton leak, and non-mitochondrial respiration), mitochondrial stress (mass of superoxide per mitochondrial mass) and oxidative phosphorylation in each complex (densitometric analysis by western blot)
**Sepsis-related organ failure assessment score, is used to track a person's status to determine the extent of a person's organ function. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Score range from 0 to 20, if SOFA score increase at least 2 points, sepsis will be diagnosis.
Measured: since emergency department admission until blood examination was collected, up to 24 hours.
To investigate the association of level of mitochondrial function in sepsis with central venous oxygen saturation (ScvO2)
The correlation between these physiologic/biomarkers and mitochondrial function* will be evaluated. ScvO2 separated in low, normal and high group (<70%, 70-80%, >80%). Each ScvO2 group calculate mitochondrial function in mean and analysis mean difference.
*Mitochondrial function are mitochondrial respiration (Oxygen consumption rate in basal respiration, ATP production, maximal respiration, spare capacity, proton leak, and non-mitochondrial respiration), mitochondrial stress (mass of superoxide per mitochondrial mass) and oxidative phosphorylation in each complex (densitometric analysis by western blot)
Measured: since emergency department admission until patient disposition form emergency department, up to 24 hours.
To investigate the association of level of mitochondrial function in sepsis with serum lactate.
The correlation between these physiologic/biomarkers and mitochondrial function* will be evaluated. Serum lactate separated in normal and high group (<2 mmol/L and >=2 mmol/L), . Each serum lactate group calculate mitochondrial function in mean and analysis mean difference.
*Mitochondrial function are mitochondrial respiration (Oxygen consumption rate in basal respiration, ATP production, maximal respiration, spare capacity, proton leak, and non-mitochondrial respiration), mitochondrial stress (mass of superoxide per mitochondrial mass) and oxidative phosphorylation in each complex (densitometric analysis by western blot)
Measured: since emergency department admission until patient disposition form emergency department, up to 24 hours.
To investigate the association of level of mitochondrial function in sepsis with venous-to-arterial carbon dioxide tension difference (delta PCO2).
The correlation between these physiologic/biomarkers and mitochondrial function* will be evaluated. Delta PCO2 in normal and high group (<6 mmHg, >=6mmHg). Each group of Delta PCO2 calculate mitochondrial function in mean and analysis mean difference.
*Mitochondrial function are mitochondrial respiration (Oxygen consumption rate in basal respiration, ATP production, maximal respiration, spare capacity, proton leak, and non-mitochondrial respiration), mitochondrial stress (mass of superoxide per mitochondrial mass) and oxidative phosphorylation in each complex (densitometric analysis by western blot)
Measured: since emergency department admission until patient disposition form emergency department, 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 posted21 Nov 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients for aim#3 will be randomly assigned in a 1:1 ratio of hydrocortisone and no hydrocortisone administration (control group), in a block of four patterns. Serum cortisol will be collected before administration. Hydrocortisone will be administered intravenously at 200 mg every 24 hours for 5 days, then tapered to a 50 mg intravenous bolus every 12 hours for days 6 to 8 and 50 mg every 24 hours for days 9 to 11, and then stopped. In control group, patient will not receive any corticosteroids for seven day after inclusion.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borwon Wittayachamnankul, Chiang Mai University
- Investigators
- BORWON WITTAYACHAMNANKUL, MD, Principal investigator, Emergency Department, Medicine Faculty, Chiang Mai University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748537
- Sponsor's protocol ID
- EME-2559-04262
- Acronym
- MtiSS
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Function in Septic Patients
- ClinicalTrials.gov ID
- NCT03748537
- Acronym / sponsor ID
- MtiSS / EME-2559-04262
- Conditions
- Sepsis, Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 21 Nov 2018 (actual)
- 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.
Aim #1 To investigate the prevalence, risk and correlation of the level of sepsis with mitochondrial dysfunction in sepsis patients Aim 1.1 To investigate the prevalence of mitochondria dysfunction among sepsis patients Aim 1.2 To investigate the risk associated with mitochondrial dysfunction in sepsis patients.
Aim 1.3 To investigate the association between sepsis severity (SOFA scoring system) and the degree of mitochondrial dysfunction Aim #2 To investigate the association of mitochondrial dysfunction in sepsis with ScvO2, lactate and ∆PCO2 Aim 3.1 To investigate the therapeutic efficacy of steroids on the improvement mitochondrial function in sepsis patients Aim 3.2. To investigate the efficacy of steroids on the reduction mortality rate in sepsis patients with norepinephrine-resistant hypotension
Detailed description
Aim #1 To investigate the prevalence, risk and correlation of the level of sepsis with mitochondrial dysfunction in sepsis patients Aim 1.1 To investigate the prevalence of mitochondria dysfunction among sepsis patients Hypothesis: Most of sepsis patients are affected by mitochondria dysfunction. Since there are many suspected cases of sepsis in the emergency department, mitochondrial function measurements will be collected. After the patients are diagnosed, the degree of mitochondrial function will be reported as a percent among all of sepsis patients.
Aim 1.2 To investigate the risk associated with mitochondrial dysfunction in sepsis patients.
Hypothesis: Some risks other than infection are associated with mitochondrial dysfunction in septic patient.
Since there are many suspected cases of sepsis in the emergency department, mitochondrial function measurements will be collected. After the patients are diagnosed, the degree of mitochondrial function will be reported at intervals. Additionally, the correlation among sex, age, obesity, underlying symptoms, cause of infection, pathogen, onset of fever before emergency department visit, number of organ dysfunction, presence of shock and other hemodynamic parameter will be collected.
Aim 1.3 To investigate the association between sepsis severity (SOFA scoring system) and the degree of mitochondrial dysfunction Hypothesis: The severity of sepsis and organ dysfunction are associated with the severity of mitochondrial dysfunction.
Since there are many suspected cases of sepsis in the emergency department, mitochondrial function measurements will be collected. After the patients are diagnosed, the degree of mitochondrial function will be reported at intervals along with the correlation with the severity of sepsis in SOFA scoring system.
Aim #2 To investigate the association of mitochondrial dysfunction in sepsis with ScvO2, lactate and ∆PCO2 Hypothesis: Persistence of high lactate and extreme change of ScvO2 or ∆PCO2 after sepsis bundle care are associated with severity of mitochondrial dysfunction.
Since patients are suspected of having sepsis with hypoperfusion (1. Blood lactate > 4 mmol/L, 2. Refractory hypotension: after bolus fluid 20 mL/kg and Systolic Blood Pressure still < 90 mmHg or require vasopressor), the sepsis bundle care will be started in the emergency department. The goals of this treatment are 1. A mean arterial pressure of > 65 is achieved by fluid resuscitation and vasopressor, 2. Lactate > 4 mmol/L or ScvO2 > 70 is achieved. After 6 hours following the beginning of resuscitation, blood examination for mitochondrial function, ScvO2 and ∆PCO2 will be determined. The correlation between these physiologic/biomarkers and mitochondrial function will be evaluated.
Aim #3 To investigate the roles of steroid administration on mitochondrial function in sepsis patients (Therapeutic trial) Aim 3.1 To investigate the therapeutic efficacy of steroids on the improvement mitochondrial function in sepsis patients Hypothesis: Steroids administration improve mitochondrial function in norepinephrine-resistant sepsis.
After resuscitation, hypoperfusion in the sepsis patients will be treated by fluid resuscitation and vasopressor. Some groups of patients may be not responsive to this treatment (MAP <65 mmHg), administration of steroids to this group will be blindly randomized (treatment and control group). During resuscitation of septic shock patients with fluid resuscitation and vasopressors, some may not respond to treatment (MAP < 65 mmHg). Patients who have shock refractory to fluid resuscitation and norepinephrine therapy for more than 0.5 mcg/kg/min will be blindly randomized to receive steroid (treatment group) or placebo (control group). Blood samples will be obtained to determine mitochondrial functioning before, at day 1 and day 7 after administration of study medications in both groups.
Aim 3.2. To investigate the efficacy of steroids on the reduction mortality rate in sepsis patients with norepinephrine-resistant hypotension Hypothesis: Steroids improve survival in septic shock patients with norepinephrine-resistant hypotension.
During resuscitation of septic shock patients with fluid resuscitation and vasopressors, some may not respond to treatment (MAP < 65 mmHg). Patients who have shock refractory to fluid resuscitation and norepinephrine administration more than 0.5 mcg/kg/min will be blindly randomized to receive steroid (treatment group) or placebo (control group). Blood samples will be obtained to determine mitochondrial functioning before, at day 1 and day 7 after administration of study medications in both groups. Thirty-day survival will be analyzed by a survival analysis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Eligible patients for aim#3 will be randomly assigned in a 1:1 ratio of hydrocortisone and no hydrocortisone administration (control group), in a block of four patterns. Serum cortisol will be collected before administration. Hydrocortisone will be administered intravenously at 200 mg every 24 hours for 5 days, then tapered to a 50 mg intravenous bolus every 12 hours for days 6 to 8 and 50 mg every 24 hours for days 9 to 11, and then stopped. In control group, patient will not receive any corticosteroids for seven day after inclusion.
| Arm | Type | Receives |
|---|---|---|
| Hydrocortisone | Experimental | Drug: HydrocortisoneHydrocortisone will be administered intravenously at 200 mg every 24 hours for 5 days, then tapered to a 50 mg intravenous bolus every 12 hours for days 6 to 8 and 50 mg every 24 hours for days 9 to 11, and then stopped. |
| No Hydrocortisone | No intervention | –In control group, patient will not receive any corticosteroids for seven day after inclusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years of age)
- Diagnosis of sepsis within 1 hour after presentation to the emergency department: known or presumed infection and SOFA score > 2 (table1)
- Norepinephrine-resistant hypotension (refractory hypotension and not response to norepinephrine dose ≥ 0.5 mcg/k/min)
Key exclusion criteria (23 listed)
- Known pregnancy
- Primary diagnosis of:
- Hemodynamic instability due to active hemorrhage
- Requirement for immediate surgery
- Do-Not-Attempt-Resuscitation (DNAR) order
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 |
|---|---|---|
| HydrocortisoneAlso: CortisolAfter resuscitation, hypoperfusion in the sepsis patients will be treated by fluid resuscitation and vasopressor. Some groups of patients may be not responsive to this treatment (MAP <65 mmHg), administration of steroids to this group will be blindly randomized (treatment and control group). During resuscitation of septic shock patients with fluid resuscitation and vasopressors, some may not respond to treatment (MAP < 65 mmHg). Patients who have shock refractory to fluid resuscitation and norepinephrine therapy for more than 0.5 mcg/kg/min will be blindly randomized to receive steroid (treatment group) or placebo (control group). Blood samples will be obtained to determine mitochondrial functioning before, at day 1 and day 7 after administration of study medications in both groups. | Drug | Hydrocortisone |
Primary outcome
To investigate the level of mitochondrial respiration after steroid administration
Time frame: 7 days
Mean level comparative of mitochondrial respiration* in "Hydrocortisone" and "No intervention" groups will be investigated at before, day 1 after and day 7 after administration of intervention. *Mitochondrial function are mitochondrial respiration (Oxygen consumption rate in basal respiration, adenosine triphosphate (ATP) production, maximal respiration, spare capacity, proton leak, and non-mitochondrial respiration; Report in picomole/min)
To investigate the level of mitochondrial stress after steroid administration
Time frame: 7 days
Mean level comparative of mitochondrial stress* in "Hydrocortisone" and "No intervention" groups will be investigated at before, day 1 after and day 7 after administration of intervention. *Mitochondrial stress (mass of superoxide per mitochondrial mass) and oxidative phosphorylation in each complex (densitometric analysis by western blot)
To evaluate survival in septic patients who have refractory shock after steroid administration
Time frame: 28 days
Evaluate survival comparison in "Hydrocortisone" and "No intervention" groups. In 28 days survival and survival analysis until 28 day.
5 secondary outcomes
To investigate risk factor (Age, underlying disease, number of organ dysfunction) correlation with the mitochondrial function in sepsis patients
Time frame: since emergency department admission until blood examination was collected, up to 24 hours.
To investigate severity level of sepsis (SOFA Score) correlation with the mitochondrial function in sepsis patients
Time frame: since emergency department admission until blood examination was collected, up to 24 hours.
To investigate the association of level of mitochondrial function in sepsis with central venous oxygen saturation (ScvO2)
Time frame: since emergency department admission until patient disposition form emergency department, up to 24 hours.
To investigate the association of level of mitochondrial function in sepsis with serum lactate.
Time frame: since emergency department admission until patient disposition form emergency department, up to 24 hours.
To investigate the association of level of mitochondrial function in sepsis with venous-to-arterial carbon dioxide tension difference (delta PCO2).
Time frame: since emergency department admission until patient disposition form emergency department, up to 24 hours.
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 27 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Sepsis
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
RecruitingObservational study
Metabolic and Functional Study of γδ T Cells in Critically Ill Patients
Sepsis, Critical Illness
Not yet recruiting
Blood Purification in Septic Children
Sepsis, Blood Purification
Active, not recruitingObservational study
Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool
Sepsis
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
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.
BORWON WITTAYACHAMNANKUL, MD principal investigator
Emergency Department, Medicine Faculty, Chiang Mai University, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrocortisone in people with Sepsis and Septic Shock, run by Chiang Mai University 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 3 inclusion and 23 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 27 Jan 2020. 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.
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?
To investigate the level of mitochondrial respiration after steroid administration (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 27 Jan 2020.