Trial · NCT05179499
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary objective is to determine whether early PVI (within 12 hours of admission) targeted to MAP of ≥65 mmHg improves clinical effectiveness in hospitalised adult patients with septic shock compared with usual care, in the first 48 hours. | 90 days post randomisation | The primary objective is measured by the Primary outcome of 'Days Alive and Out of Hospital at 90 Days'. |
| Secondary | Accumulated Total Volume of IV fluid | 6,12, 24, 48 and 72 hours post randomisation | Accumulated volume of IV fluid delivered in each arm - excluding fluid volumes less than 100ml |
| Secondary | Lactate clearance from baseline | 6, 12, 24, 48 & 72 hours post randomisation | Blood lactate value - arterial or venous |
| Secondary | Total Dose of Norepinephrine | 6, 12, 24, 48 and 72 hours post randomisation | Total dose of norepinephrine delivered by any route (peripheral or central) at each timepoint |
| Secondary | Proportion of patients who receive vasopressors | 6, 12, 24 and 48 hours after recruitment to the control arm | Proportion of patients recruited to control arm who receive any vasopressor (norepinephrine, vasopressin, metarminol, epinephrine) at each time point |
| Secondary | Proportion of patients who require central venous access | 24 and 48 hours post randomisation | Decision to treat based on treating clinician judgement |
| Secondary | Proportion of patients developing acute kidney injury | During the first 72 hours post randomisation | Acute kidney injury in line with the (p) RIFLE (paediatric Risk, Injury, Failure, Loss, End stage renal disease, AKIN (Acute kidney injury network) or KDIGO (Kidney Disease: Improving Global Outcomes) definitions by using any of the following criteria * a rise in serum creatinine of 26 micromol/litre or greater within 48 hours * a 50% or greater rise in serum creatinine known or presumed to have occurred within the past 7 days * a fall in urine output to less than 0.5 ml/kg/hour for more than 6 hours in adults |
| Secondary | Proportion of patients receiving parenteral corticosteroid | 24, 48 & 72 hours post randomisation | defined as new prescription of parenteral corticosteroid |
| Secondary | Length of hospital stay for index admission | up to hospital discharge | index hospital admission ends when the patient is discharged from the facility providing definitive treatment for the episode of sepsis leading to inclusion in the study |
| Secondary | Proportion of participants needing renal replacement therapy during index hospital admission | index admission | decision to treat based on treating clinician judgement; participants who receive new renal replacement therapy; participants with chronic renal replacement initiated prior to the index admission will not be eligible to meet this endpoint |
| Secondary | Proportion of participants needing non-invasive ventilation during index hospital admission | index admission | decision to treat based on treating clinician judgement; defined as admissions receiving mask/hood CPAP or mask/hood BiPAP or non-invasive ventilation; admissions receiving CPAP via a tracheostomy |
| Secondary | Proportion of participants needing advanced respiratory support (ICNARC definition) | index admission | decision to treat based on treating clinician judgement; Patients who receive one or more of the following: A. Patients who receive invasive mechanical ventilation via endotracheal or tracheostomy tube, except those intubated solely for a procedure and extubated within 24 hours B. BiPAP (bilevel positive airway pressure) applied via a trans-laryngeal tracheal tube or applied via a tracheostomy C. CPAP (continuous positive airway pressure) via a translaryngeal tune of applied via a tracheostomy D. extracorporeal respiratory support |
| Secondary | Total dose of other vasopressor | 6, 12, 24, 48, 72 hours post randomisation | Total dose of other vasopressors delivered by any route (peripheral or central) at each timepoint |
| Secondary | All-cause mortality during index hospital admission and at 30 and 90 days | index admission and at 30 & 90 days post randomisation | All-cause mortality during index hospital admission and at 30 \& 90 days post randomisation |
| Secondary | Readmission, post initial hospital discharge, in first 30 days and 90 days post randomisation | 30 & 90 days post randomisation | Re-admission to an acute healthcare facility in the first 30 \& 90 days post randomisation, following a discharge from the index hospital admission to the participants care setting in the community. This includes planned and unplanned admissions. For both readmission outcomes, an acute care facility is any acute care hospital, emergency department admission \>24 hours, critical care area or short stay admission or observation area. |
| Secondary | Proportion of participants admitted to and length of stay in critical care (level 2 or 3) during index hospital admission | During Index Hospital Admission | Proportion of participants admitted to and length of stay in critical care (level 2 or 3) during index hospital admission |
| Secondary | Discharge Diagnosis | At initial Index Hospital Discharge & at any subsequent hospital discharges following any re-admissions (post Initial Index Hospital Discharge) 90 days post randomisation. | Main diagnosis for index hospital admission, and all subsequent re-admissions |
| Secondary | HRQoL | Baseline, 30 & 90 Days Post randomisation | Derived from EQ-5D-5L index values |
| Other | Patient Centred Outcome | 30 days post randomisation | organ support free days at 30 days |
| Other | Protocol Adherence | 48 hours post randomisation | Proportion of patients who have PVI discontinued for non-clinical reasons after recruitment to intervention arm |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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