A Phase 2/3 interventional study of Simultaneous administration of vasopressors and Successive administration of vasopressors in Shock, Septic, sponsored by University Medical Centre Maribor. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by University Medical Centre Maribor · Phase 2/3, Interventional, and Treatment
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The goal of this prospective randomized controlled trial is to compare the effects of classic stepwise vs. early balanced multimodal vasopressor strategies in septic shock.
CONTROL GROUP(Classic stepwise vasopressor administration):
Patients will be started on norepinephrine with increases of 0.05-0.1 mcg/kg/min up to 0.5 mcg/kg/min, followed by vasopressin (administered at a fixed dose of 0.03 IE/min). If MAP remains \< 65 mmHg, norepinephrine will be titrated above dose of 0.5 mcg/kg/min until MAP ≥ 65 mmHg. Initiation of additional vasoactive drugs (epinephrine, Ang II, methylene blue or dopamine) as per clinical team decision. Initiation of inotropes (dobutamine, milrinone, levosimendan) as per clinical team decision.
EXPERIMENTAL GROUP(Balanced multimodal vasopressor administration):
Early, simultaneous start of norepinephrine, angiotensin II and vasopressin at equivalent starting doses (equivalent to approximately 0.05 mcg/kg/min of norepinephrine). Increments of 0.05 mcg/kg/min of equivalent doses of all three vasopressors every 3-5 min until MAP ≥ 65 mmHg is reached (vasopressin will be administered at a maximum dose of 0.03 IE/min, Ang II will be administered at maximum dose of 100ng/kg/min). Initiation of additional vasoactive drugs (epinephrine, methylene blue or dopamine) as per clinical team decision. Initiation of inotropes (dobutamine, milrinone, levosimendan) as per clinical team decision.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's enrollment of 79 is close to the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →University Medical Centre Maribor is the lead sponsor of 37 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Regimen: Norepinephrine increases of 0.05-0.1 mcg/kg/min up to 0.5 mcg/kg/min, followed by vasopressin (administered at a fixed dose of 0.03 IE/min). If MAP remains \< 65 mmHg, norepinephrine will be titrated above dose of 0.5 mcg/kg/min until MAP ≥ 65 mmHg. Maximum norepinephrine dose as per clinical team decision. Initiation of additional vasoactive drugs (epinephrine, Ang II methylene blue or dopamine) as per clinical team decision. Initiation of inotropes (dobutamin, levosimendan, milrinone) as per clinical team decision.
Other: Successive administration of vasopressors
Regimen: Simultaneous administration of norepinephrine, angiotensin II and vasopressin at equivalent starting doses (equivalent to approximately 0.05 mcg/kg/min of norepinephrine). Increments of 0.05 mcg/kg/min of equivalent doses of all three vasopressors every 3-5 min until MAP ≥ 65 mmHg is reached (vasopressin will be administered at a maximum dose of 0.03 IE/min, AT II will be administered at a maximum dose of 100 ng/kg/min). Initiation of additional vasoactive drugs (epinephrine, methylene blue or dopamine) as per clinical team decision. Initiation of inotropes (dobutamin, levosimendan, milrinone) as per clinical team decision.
Other: Simultaneous administration of vasopressors
Early, simultaneous administration of norepinephrine, angiotensin II, and vasopressin.
Administration and titration of norepinephrine and vasopressin. Administration of additional vasoactive drugs (epinephrine, methylene blue, angiotensin II or dopamine) as per clinical team. Initiation of inotropes (dobutamin, levosimendan, milrinone) as per clinical team decision.
Rate of change in renin levels
There is an increasing amount of data that renin is the best marker of tissue hypoperfusion and predictor of ICU mortality in patients with sepsis and septic shock, even outperforming lactate. Renin increased between the first and third day in non-survivors, but dropped in survivors. The rate of change in renin concentration but not lactate concentration in ICU patients over first 72 hours is associated with in hospital mortality.
Time frame: 72 hours
Compare lactate levels
In critically ill patients, plasma lactate is commonly used to guide hemodynamic resuscitation. Hyperlactatemia has been widely recognized as a marker of tissue hypoxia/hypoperfusion but it can also result from increased or accelerated aerobic glycolysis during the stress response and may represent an important energy source in critically ill patients. Resuscitation to normalize lactate levels could worsen physiological status.
Time frame: 72h
Compare Δ Sequential Organ Failure Assessment (SOFA) score
The purpose is to monitor the rate of organ dysfunction. Score ranges from 0 (best) to 24 (worst) points.
Time frame: 72 hours
Compare acute kidney injury rate
The purpose is to monitor acute kidney injury based on Improving Global Outcomes (KDIGO) definition and staging system.
Time frame: 72 hours
Survival to ICU discharge
Time frame: From date of ICU admission until date of ICU discharge or death during ICU stay whichever came first, assessed up to 8 weeks
28-day mortality
Time frame: 28 days after first admission to the ICU
Renal replacement therapy requirement during ICU stay.
Time frame: From date of ICU admission until date of ICU discharge or death during ICU stay whichever came first, assessed up to 8 weeks
Vasopressor cumulative dose requirement.
Time frame: 72 hours
Quality of life assessment 90 days after ICU admission (using EQ-5D standardized questionnaire).
Time frame: 90 days after ICU admission if alive
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Informed consent form
Time frame: After November 2026
Ran from Dec 2023 to primary completion in Dec 2025, 24 months.
Of 13 phase 2/3 interventional studies under Shock, Septic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University Medical Centre Maribor