Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06155812
Other study ID # IRP-2023/01-03
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date November 3, 2023
Est. completion date November 2026

Study information

Verified date December 2023
Source University Medical Centre Maribor
Contact Žiga Kalamar, MD
Phone +386 2 321 2471
Email ziga.kalamar94@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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, methylene blue, angiotensin II, dobutamine, or dopamine) 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date November 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients (= 18 years) - Sepsis (an acute change in total SOFA score =2 points consequent to infection) with persisting hypotension requiring vasopressors to maintain MAP = 65 mm Hg and having a serum lactate level >2 mmol/L despite adequate volume resuscitation - Patients must have a Cardiac Index (CI) >2.3 L/min/m2 (measured by bedside echocardiography, PiCCO catheter, or Swan-Ganz catheter) Exclusion Criteria: - Death expected < 24 hours - Pregnancy (suspected or confirmed) - Surgery is expected for the source of the infection - Inter-hospital transfer is expected during the first 72 hours of hospitalization - Liver failure with a Model for End-Stage Liver Disease (MELD) score of = 30 (3 months observed mortality at 52.6 %) - Patients on VA-ECMO - Known allergy to mannitol - Patients with systemic sclerosis or Raynaud syndrome

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Simultaneous administration of vasopressors
Early, simultaneous administration of norepinephrine, angiotensin II, and vasopressin.
Successive administration of vasopressors
Administration and titration of norepinephrine and administration of additional vasoactive drugs (epinephrine, methylene blue, angiotensin II, dobutamine, or dopamine) as per clinical team.

Locations

Country Name City State
Slovenia Medical intensive care unit UMC Maribor Maribor

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Maribor

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Other Survival to ICU discharge From date of ICU admission until date of ICU discharge or death during ICU stay whichever came first, assessed up to 8 weeks
Other 28-day mortality 28 days after first admission to the ICU
Primary 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. 72 hours
Secondary 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. 72 hours
Secondary Compare ? 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. 72 hours
Secondary Compare acute kidney injury rate The purpose is to monitor acute kidney injury based on Improving Global Outcomes (KDIGO) definition and staging system. 72 hours
See also
  Status Clinical Trial Phase
Recruiting NCT03592693 - Vitamin C, Hydrocortisone and Thiamine for Septic Shock Phase 2
Terminated NCT01639664 - COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2 N/A
Withdrawn NCT01601938 - Selenium Replacement and Serum Selenium Level in Severe Sepsis and Septic Shock Patients Phase 2
Recruiting NCT00335907 - Protocol-driven Hemodynamic Support for Patients With Septic Shock N/A
Completed NCT00000574 - Ibuprofen in Sepsis Study Phase 3
Recruiting NCT04910841 - Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine N/A
Active, not recruiting NCT04079829 - Postoperative Respiratory Abnormalities
Recruiting NCT04569942 - Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis Phase 3
Recruiting NCT04934943 - "Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools"
Completed NCT01310790 - Strategy of Early Improvement of Tissue Oxygenation Decrease the Mortality of Severe Sepsis and Septic Shock Phase 4
Completed NCT00241228 - Haemofiltration Study : IVOIRE (hIgh VOlume in Intensive Care) N/A
Completed NCT00046072 - A Safety and Efficacy Study of Intravenous E5564 in Patients With Severe Sepsis Phase 2
Withdrawn NCT03122678 - Thiamine Supplementation in Patients With Septic Shock Phase 1
Completed NCT04178148 - Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock N/A
Completed NCT01453270 - Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial N/A
Completed NCT04576819 - Role and Mechanisms of Lipid and Lipoprotein Dysregulation in Sepsis
Active, not recruiting NCT04055909 - Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock Phase 2
Suspended NCT03193164 - Neuromuscular Electrical Stimulation and Septic Shock N/A
Completed NCT04647552 - Effects of Hydrocortison Treatment on Angiotensin II and Angiotensin II Receptors in Patients With Septic Shock
Withdrawn NCT02454348 - NOrepinephrine and VasoprEssin Versus Norepinephrine aLone in Critically Ill Patients With Septic Shock Phase 4