Authorised Therapeutic use (Phase IV) Septic shock

Renal Outcomes in the early use of vasopressin in the treatment of septic shock

EU CTIS ID: 2023-509071-16-00

What this study is testing

The primary objective of the study is to verify whether the earlier association of vasopressin and norepinephrine determines variations in terms of the use of renal function replacement techniques in the first 7 days of hospitalization in the Intensive Care Unit (ICU), compared to patients in whom the vasopressin is added only when norepinephrine reaches a higher dosage.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Patients suffering from septic shock hospitalized in an intensive setting within 24 hours of clinical diagnosis
  • Capable of expressing informed consent to treatment
  • Aged over 18 years and under 80 years of age
  • Male and female
  • Norepinephrine dosage equal to or greater than 0.25 mcg/kg/min according to the patient's ideal weight (IBW)

You likely can't join if

  • Patients in the absence of consent to participate in the study and to the processing of personal and particular data
  • Patients with allergy/intolerance to the drugs used in the study
  • Pregnant patients
  • Patients who need to start renal replacement treatment within 24 hours of admission to the ICU for dialysis emergencies that cannot be deferred
  • Patients with a history of end-stage renal failure or already undergoing dialysis treatment (CKD stages 4 and 5, with glomerular filtration < 30 ml/min)
  • Norepinephrine dosage equal to or greater than 0.5 mcg/kg/min according to the patient's ideal weight (IBW) at enrollment time
See the full eligibility criteria
Who can join
  • Patients suffering from septic shock hospitalized in an intensive setting within 24 hours of clinical diagnosis
  • Capable of expressing informed consent to treatment
  • Aged over 18 years and under 80 years of age
  • Male and female
  • Norepinephrine dosage equal to or greater than 0.25 mcg/kg/min according to the patient's ideal weight (IBW)
What rules you out
  • Patients in the absence of consent to participate in the study and to the processing of personal and particular data
  • Patients with allergy/intolerance to the drugs used in the study
  • Pregnant patients
  • Patients who need to start renal replacement treatment within 24 hours of admission to the ICU for dialysis emergencies that cannot be deferred
  • Patients with a history of end-stage renal failure or already undergoing dialysis treatment (CKD stages 4 and 5, with glomerular filtration < 30 ml/min)
  • Norepinephrine dosage equal to or greater than 0.5 mcg/kg/min according to the patient's ideal weight (IBW) at enrollment time
  • Single kidney patients
  • Patients with bilateral renal hypoplasia
  • Patients undergoing kidney transplant
  • Patients undergoing haemoperfusion with an adsorbent cartridge for bacterial endotoxin
  • Patients under 18 years of age or over 80 years of age
  • Patients who died within the first 24 hours of admission to the ICU
  • Patients requiring a norepinephrine dosage lower than 0.25 mcg/kg/min in the first 24 hours of hospitalization in the ICU
  • Patients with recent acute coronary syndrome (within the previous 7 days)

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.