SepsisCENSER2NCT07343206
Early Norepinephrine Administration and Rapid Dose Adjustment
A study testing Early norepinephrine administration and rapid dose adjustment in people with Sepsis and Septic Shock, run by Siriraj Hospital at 6 sites in Thailand.
Trial summary
The goal of this clinical trial is to determine whether early initiation of norepinephrine with rapid dose adjustment improves clinical outcomes in adult patients with septic shock. 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?
- Early norepinephrine administration and rapid dose adjustment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 6 sitesThailand
- Study dates
- 1 Jan 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Sepsis: SOFA ≥2 with suspected infection
- Mean arterial pressure <65 mmHg
- Diagnosed within 3 hours
Who cannot join
- Do-not-resuscitate orders
- Pregnancy
- Severe concurrent conditions (acute stroke, acute coronary syndrome, acute pulmonary edema, status asthmaticus, active gastrointestinal bleeding, status epilepticus, severe burn, severe trauma, and fatal drug overdose, End-stage malignancy
- Peripheral arterial disease
- Prior norepinephrine administration
- Recurrent shock in the same patient
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Thailand6 sites, 6 recruiting
- Recruiting
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
Wasin Pansiritanachot, Medical Doctor, +66 89 680 8508, dr.wasinpan@gmail.com
Wasin Pansiritanachot, Medical Doctor
- Recruiting
Hatyai Hospital
Hat Yai, Hat Yai, 90110
Suratee Chobngam, +66074273100, areefsu123@gmail.com
Suratee Chobngam, Medical Doctor
- Recruiting
Kalasin Hospital
Kalasin, Changwat Kalasin, 46000
Suwimon Khansompop, +66942346394, yoyeeko@gmail.com
Suwimon Khansompop, Medical Doctor
- Recruiting
Khon Kaen hospital
Khon Kaen, Changwat Khon Kaen, 4000
Porntipa Tantibundit, +66815623688, tanti.porntipa@gmail.com
Porntipa Tantibundit, Medical Doctor
- Recruiting
Maharaj Nakhon Si Thammarat Hospital
Nakhon Si Thammarat, ์Nakhon Si Thammarat, 8000
Katsakorn Kheawkaew, +66886266464, katsakorn@gmail.com
Katsakorn Kheawkaew, Medical Doctor
- Recruiting
Udon Thani Hospital
Udon Thani, Changwat Udon Thani, 41000
Anutr Thitayanapong, +66802598884, Anutr.thi@gmail.com
Anutr Thitayanapong, Medical Doctor
About this study
Official title: Efficacy of Early Norepinephrine Administration and Rapid Dose Adjustment in Adult Septic Shock Patients: A Multicenter Randomized Controlled Trial
The goal of this clinical trial is to determine whether early initiation of norepinephrine with rapid dose adjustment improves clinical outcomes in adult patients with septic shock. The study aims to evaluate the effect of early norepinephrine administration on mortality, hemodynamic stabilization, and resuscitation efficiency in adults aged 18 years and older diagnosed with septic shock.
The main questions it aims to answer are:
Read more
- Does early norepinephrine administration with rapid dose titration reduce 28-day mortality compared with standard treatment?
- Does early norepinephrine administration with rapid dose tiration lead to faster shock control and reduced fluid requirements without increasing treatment-related adverse events?
Researchers will compare early norepinephrine administration with rapid dose adjustment to placebo with standard sequential resuscitation and rescue norepinephrine as needed to see if early vasopressor initiation improves survival, shock resolution, and safety outcomes.
Participants will:
- Receive either norepinephrine or placebo infusion initiated within one hour of septic shock diagnosis, with dose adjustment every 15 minutes according to a standardized protocol
- Undergo close hemodynamic and safety monitoring, including frequent vital sign assessment and limb perfusion evaluation
- Receive standard sepsis care, including fluid resuscitation, antibiotics, and organ support as clinically indicated
- Be followed for clinical outcomes and adverse events for up to 28 days after enrollment
- Conditions
- Sepsis, Septic Shock
- Being tested
- Early norepinephrine administration and rapid dose adjustment, Control
- Keywords
- septic shock, norepinephrine, sepsis, hypotension
- Medical subject headings
- Sepsis, Shock, Septic, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early norepinephrine administration and rapid dose adjustmentDrug
Norepinephrine 4 mg in 250 mL D5W, initiated at 0.05 mcg/kg/min. Titrate by 0.025 mcg/kg/min every 15 minutes if MAP <65 mmHg, up to 0.15 mcg/kg/min maximum. Rescue norepinephrine available if needed (separate line). Limb ischemia monitoring every 15 minutes.
Duration: 24 hours.
ControlDrug
Placebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Norepinephrine 4 mg in 250 mL D5W, initiated at 0.05 mcg/kg/min. Titrate by 0.025 mcg/kg/min every 15 minutes if MAP <65 mmHg, up to 0.15 mcg/kg/min maximum. Rescue norepinephrine available if needed (separate line). Limb ischemia monitoring every 15 minutes.
Duration: 24 hours. Receives: Drug: Early norepinephrine administration and rapid dose adjustment |
| Control | Sham comparator | Placebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day survival
Survival at 28-day after enrollment. Telephone follow-up for patients who are discharged before 28 days.
Measured: From enrollment to 28 days after enrollment
Secondary outcomes (10)
Number of participants with shock control achieved
Shock control defined as mean arterial pressure greater than 65 mmHg combined with urine output greater than 0.5 milliliters per kilogram per hour OR lactate clearance greater than 10 percent within 6 hours
Measured: From enrollment to 6 hours after enrollment
Duration of intensive care unit stay
Days of intensive care unit stay
Measured: From enrollment to hospital discharge or 90 days (whichever comes first)
Duration of hospital stay
Days of hospital stay
Measured: From enrollment to hospital discharge or 90 days (whichever comes first)
Duration of mechanical ventilation
Days on mechanical ventilation, including endotracheal tube and tracheostomy
Measured: From enrollment to hospital discharge or 90 days (whichever comes first)
Duration of renal replacement therapy
Days requiring renal replacement therapy, including continuous renal replacement therapy, intermittent hemodialysis, and peritoneal dialysis, that is newly initiated during this admission. Maintaining chronic hemodialysis is excluded.
Measured: From enrollment to hospital discharge or 90 days (whichever comes first)
Duration of vasopressor therapy
Days requiring vasopressor therapy
Measured: From enrollment to hospital discharge or 90 days (whichever comes first)
Time to Achievement of Early Goal-Directed Therapy Targets
Time in hours to achieve ALL EGDT targets: MAP ≥65 mmHg, urine output ≥0.5 mL/kg/hr, lactate clearance ≥10%, and ScvO₂ ≥70% (when measured)
Measured: From study drug initiation until achievement of all EGDT targets or up to 6 hours
Cumulative Fluid Volume Administered
Total volume in milliliters of intravenous crystalloid and colloid fluids administered during first 24 hours and first 72 hours Time Frame: At 1 hour, 6 hours, 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3) after treatment initiation
Measured: Multiple assessments at: - Before randomization (baseline) - 1 hour after study drug initiation - 6 hours after study drug initiation - 24 hours (Day 1) 48 hours (Day 2) 72 hours (Day 3) after study drug initiation
Incidence of Pulmonary Edema
New-onset cardiogenic pulmonary edema or non-cardiogenic pulmonary edema
Measured: From diagnosis until hospital discharge 90 days or death
Treatment-Related Adverse Events Including Cardiac Arrhythmias
Composite outcome including new-onset arrhythmias (AF, AFL, SVT, VT, VF, AV block, bradycardia), limb/mesenteric ischemia, skin necrosis, and severe hypertension
Measured: From study drug initiation until hospital discharge or death, assessed 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jan 2026
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maharaj Nakorn Si Thammarat, Kalasin Hospital, Khon Kaen Hospital, Udon Thani Regional Hospital, Hat Yai Hospital
- Responsible party
- Principal investigator, Wasin Pansiritanachot, Siriraj Hospital
- Investigators
- Chairat Permpikul, Professor, Principal investigator, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343206
- Sponsor's protocol ID
- Si 930/2025
- Acronym
- CENSER2
- Status last verified
- Apr 2026
- First submitted
- 6 Jan 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified anonymized patient data will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Early Norepinephrine Administration and Rapid Dose Adjustment in Adult Septic Shock Patients: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07343206
- Acronym / sponsor ID
- CENSER2 / Si 930/2025
- Conditions
- Sepsis, Septic Shock
- Keywords
- septic shock, norepinephrine, sepsis, hypotension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Collaborators
- Maharaj Nakorn Si Thammarat, Kalasin Hospital, Khon Kaen Hospital, Udon Thani Regional Hospital, Hat Yai Hospital
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 15 Jan 2026 (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.
The goal of this clinical trial is to determine whether early initiation of norepinephrine with rapid dose adjustment improves clinical outcomes in adult patients with septic shock. The study aims to evaluate the effect of early norepinephrine administration on mortality, hemodynamic stabilization, and resuscitation efficiency in adults aged 18 years and older diagnosed with septic shock.
The main questions it aims to answer are:
- Does early norepinephrine administration with rapid dose titration reduce 28-day mortality compared with standard treatment?
- Does early norepinephrine administration with rapid dose tiration lead to faster shock control and reduced fluid requirements without increasing treatment-related adverse events?
Researchers will compare early norepinephrine administration with rapid dose adjustment to placebo with standard sequential resuscitation and rescue norepinephrine as needed to see if early vasopressor initiation improves survival, shock resolution, and safety outcomes.
Participants will:
- Receive either norepinephrine or placebo infusion initiated within one hour of septic shock diagnosis, with dose adjustment every 15 minutes according to a standardized protocol
- Undergo close hemodynamic and safety monitoring, including frequent vital sign assessment and limb perfusion evaluation
- Receive standard sepsis care, including fluid resuscitation, antibiotics, and organ support as clinically indicated
- Be followed for clinical outcomes and adverse events for up to 28 days after enrollment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Early norepinephrine administration and rapid dose adjustmentNorepinephrine 4 mg in 250 mL D5W, initiated at 0.05 mcg/kg/min. Titrate by 0.025 mcg/kg/min every 15 minutes if MAP <65 mmHg, up to 0.15 mcg/kg/min maximum. Rescue norepinephrine available if needed (separate line). Limb ischemia monitoring every 15 minutes. Duration: 24 hours. |
| Control | Sham comparator | Drug: ControlPlacebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Sepsis: SOFA ≥2 with suspected infection
- Mean arterial pressure <65 mmHg
- Diagnosed within 3 hours
Key exclusion criteria (6 listed)
- Do-not-resuscitate orders
- Pregnancy
- Severe concurrent conditions (acute stroke, acute coronary syndrome, acute pulmonary edema, status asthmaticus, active gastrointestinal bleeding, status epilepticus, severe burn, severe trauma, and fatal drug overdose, End-stage malignancy
- Peripheral arterial disease
- Prior norepinephrine administration
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 |
|---|---|---|
| Early norepinephrine administration and rapid dose adjustmentNorepinephrine 4 mg in 250 mL D5W, initiated at 0.05 mcg/kg/min. Titrate by 0.025 mcg/kg/min every 15 minutes if MAP <65 mmHg, up to 0.15 mcg/kg/min maximum. Rescue norepinephrine available if needed (separate line). Limb ischemia monitoring every 15 minutes. Duration: 24 hours. | Drug | Intervention |
| ControlPlacebo (D5W 250 mL) with an identical dosing schedule. Rescue norepinephrine available via a separate line. Same monitoring protocols. | Drug | Control |
Primary outcome
28-day survival
Time frame: From enrollment to 28 days after enrollment
Survival at 28-day after enrollment. Telephone follow-up for patients who are discharged before 28 days.
10 secondary outcomes
Number of participants with shock control achieved
Time frame: From enrollment to 6 hours after enrollment
Duration of intensive care unit stay
Time frame: From enrollment to hospital discharge or 90 days (whichever comes first)
Duration of hospital stay
Time frame: From enrollment to hospital discharge or 90 days (whichever comes first)
Duration of mechanical ventilation
Time frame: From enrollment to hospital discharge or 90 days (whichever comes first)
Duration of renal replacement therapy
Time frame: From enrollment to hospital discharge or 90 days (whichever comes first)
Duration of vasopressor therapy
Time frame: From enrollment to hospital discharge or 90 days (whichever comes first)
Time to Achievement of Early Goal-Directed Therapy Targets
Time frame: From study drug initiation until achievement of all EGDT targets or up to 6 hours
Cumulative Fluid Volume Administered
Time frame: Multiple assessments at: - Before randomization (baseline) - 1 hour after study drug initiation - 6 hours after study drug initiation - 24 hours (Day 1) 48 hours (Day 2) 72 hours (Day 3) after study drug initiation
Incidence of Pulmonary Edema
Time frame: From diagnosis until hospital discharge 90 days or death
Treatment-Related Adverse Events Including Cardiac Arrhythmias
Time frame: From study drug initiation until hospital discharge or death, assessed 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Undecided. De-identified anonymized patient data will be available upon reasonable request.
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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.
Chairat Permpikul, Professor principal investigator
Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early norepinephrine administration and rapid dose adjustment in people with Sepsis and Septic Shock, run by Siriraj Hospital at 6 sites 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 6 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Titaporn Nasaarn, Medical Doctor (+66 82 429 5514, menatitaporn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day survival (time frame: From enrollment to 28 days after enrollment). 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 22 Apr 2026.