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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Unita Sanitaria Locale Di Bologna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02], Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

22 May 2024 → ongoing

Decision date (initial)

2024-03-20

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

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.

Secondary objectives 7

1. Verify whether the early association of vasopressin improves renal function, understood as the maximum KDIGO class achieved and its evolution in the first 7 days of hospitalization in the ICU
2. Check whether the early addition of vasopressin modifies renal perfusion assessed sonographically according to CEUS method
3. Verify whether the addition of vasopressin modifies the water balance of patients in the first 48 and 72 hours after admission to the ICU
4. Verify whether early combined treatment with vasopressin reduces the duration of the need for CRRT in patients who require such support during hospitalization in the ICU
5. Verify whether the early association of vasopressin reduces the onset of supraventricular arrhythmias (atrial fibrillation - AF, atrial flutter, paroxysmal supraventricular tachycardia - PSVT) during treatment with vasopressor drugs
6. Evaluate the impact of the early association of vasopressin in terms of the onset of intestinal and/or digital and/or limb ischemia
7. Evaluate the impact of the early association of vasopressin in terms of length of stay in ICU, mortality at 28 and 90 days

Conditions and MedDRA coding

Septic shock

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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

Exclusion criteria 14

1. Patients in the absence of consent to participate in the study and to the processing of personal and particular data
2. Single kidney patients
3. Patients with bilateral renal hypoplasia
4. Patients undergoing kidney transplant
5. Patients undergoing haemoperfusion with an adsorbent cartridge for bacterial endotoxin
6. Patients under 18 years of age or over 80 years of age
7. Patients who died within the first 24 hours of admission to the ICU
8. Patients requiring a norepinephrine dosage lower than 0.25 mcg/kg/min in the first 24 hours of hospitalization in the ICU
9. Patients with recent acute coronary syndrome (within the previous 7 days)
10. Patients with allergy/intolerance to the drugs used in the study
11. Pregnant patients
12. Patients who need to start renal replacement treatment within 24 hours of admission to the ICU for dialysis emergencies that cannot be deferred
13. 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)
14. Norepinephrine dosage equal to or greater than 0.5 mcg/kg/min according to the patient's ideal weight (IBW) at enrollment time

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 30% reduction of patients satisfying the criteria for CRRT within the study group.

Secondary endpoints 7

1. Reduction of maximum KDIGO class reached in the first 7 days of hospitalization
2. Evaluation of renal perfusion using the CEUS method carried out within 24 hours of enrollment and 72 hours after the first evaluation (in terms of the presence of ischemic areas, their number and size
3. Water balance 24, 48, 72 hours after admission to the ICU
4. Number of patients meeting criteria for RRT during ICU stay
5. Number of patients who develop AF, atrial flutter or PSVT lasting more than 30 minutes and who require the introduction of new drugs for rate or rhythm control or electrical cardioversion within 24 hours of arrhythmic onset
6. Number of patients who present intestinal ischemia or extremity ischemia during the infusion of vasoactive drugs or within 3 days after the end of the administration of the aforementioned drugs
7. Length of stay in ICU and mortality at 28 and 90 days

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Unita Sanitaria Locale Di Bologna

Sponsor organisation

Azienda Unita Sanitaria Locale Di Bologna

Address

Largo Bartolo Nigrisoli 2

City

Bologna

Postcode

40133

Country

Italy

Scientific contact point

Organisation

Azienda Unita Sanitaria Locale Di Bologna

Contact name

Lorenzo Giuntoli

Public contact point

Organisation

Azienda Unita Sanitaria Locale Di Bologna

Contact name

Lorenzo Giuntoli

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications