Trial · NCT07898462
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
NCT07898462, Phase 3, Recruiting, The George Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response. Trials, record NCT07898462. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07898462
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
- NCT number
- NCT07898462
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 2,200 participants, estimated
- Lead sponsor
- The George Institute
- Conditions
- Septic Shock
- Interventions
- Fludrocortisone 50 mcg daily, Fludrocortisone 100 mcg daily, Placebo
- First posted
- 2026-10-27
- Last updated
- 2026-10-30
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Days alive and free of organ support to day 28 | From randomisation through day 28 after randomisation. | Number of days during the first 28 days after randomisation on which the participant is alive and receives none of the protocol-defined forms of organ support. Organ support is defined as treatment with a vasopressor or inotropic infusion, the need for respiratory support or the need for new renal replacement therapy. |
| Secondary | All-cause mortality | 28 days, 90 days, 6 months and 12 months after randomisation | Percentage of participants who have died from any cause by each specified follow-up time point. Mortality will be assessed separately at 28 days, 90 days, 6 months and 12 months after randomisation. |
| Secondary | Days alive and free of organ support to day 90 | From randomisation through day 90 after randomisation. | Number of days during the first 90 days after randomisation on which the participant is alive and receives none of the protocol-defined forms of organ support. Organ support is defined as treatment with a vasopressor or inotropic infusion, the need for respiratory support or the need for new renal replacement therapy. |
| Secondary | Proportion of patients treated with new-onset renal replacement therapy | From randomisation through day 90 after randomisation. | Percentage of participants who commence renal replacement therapy after randomisation and on or before day 90. |
| Secondary | Days alive and free of invasive mechanical ventilation through day 90 | From randomisation through day 90 after randomisation | Number of days during the first 90 days after randomisation on which the participant is alive and does not receive invasive mechanical ventilation |
| Secondary | Days alive and outside the intensive care unit through day 90 | From randomisation through day 90 after randomisation | Number of days during the first 90 days after randomisation on which the participant is alive and is not admitted to an intensive care unit |
| Secondary | Days alive outside hospital through day 90 | From randomisation through day 90 after randomisation | Number of days during the first 90 days after randomisation on which the participant is alive and is not admitted to hospital. |
| Secondary | Number of hospital readmissions through day 90 | 90 days after randomisation | Number of hospital readmissions per participant following discharge from the index hospital admission and occurring on or before day 90 after randomisation. |
| Secondary | Number of new-onset infections during the index hospital admission | From 2 days after randomisation until discharge from the index hospital admission. | Number of new-onset infections per participant during the index hospital admission, defined by commencement of new antibiotic treatment at least 2 days after randomisation. Antibiotics commenced for perioperative prophylaxis are excluded. Includes new-onset bacteraemia. |
| Secondary | Functional status assessed using the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 90 days, 6 months and 12 months after randomisation. | Functional status will be assessed using the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0). Each item is scored from 0 (no difficulty) to 4 (extreme difficulty or inability to perform the activity), giving a total score ranging from 0 to 48. Higher scores indicate greater disability and worse functional status. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07898462
GET https://conductscience.org/api/trials/v1/NCT07898462/registered