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NCT04635774: PODS
Post Operative Delirium Study
Phase 1, PHASE2 trial testing Insulin in Delirium. Withdrawn.
14 November 2023
Quick facts
| Lead sponsor | University of Kansas Medical Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Start date | 25 February 2021 |
| Primary completion | 14 November 2023 |
| Estimated completion | 14 November 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Insulin (insulin) — full drug profile →
- Saline
Conditions studied
- Delirium — all drugs for Delirium →
Sponsor
University of Kansas Medical Center
Who can join
65 and older, any sex, with Delirium. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Post-operative delirium happens when patients wake up from anesthesia. Patients experiencing post-operative delirium are very confused, not being able to think or function "normally". These patients are hard to take care of and they tend to have more dementia as they age compared to patients who don't experience post-operative delirium. Intranasal insulin has been shown to reverse confusion associated with Alzheimer's disease (humans) and AIDS (mice). Intranasal insulin has been safely administered to 1092 patients in 38 different studies. There were no cases of clinically low blood sugar and a few cases of mild nasal irritation that happened also with salt water when the subjects received multiple intranasal doses. No one has tried to reverse post-operative delirium with intranasal insulin. The delirium associated with Alzheimer's Disease and AIDS have very similar symptoms and what happens in the brain is very similar also. The investigators intent is to administer intranasal insulin to patients exhibiting post-operative delirium in order to reverse the symptoms because the investigators think that the three disease states are closely related and intranasal insulin has had some success in reversing the delirium in the other two disease states.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04635774
- Europe PMC full search
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Other recruiting trials for Delirium
Currently open trials in the same condition.
- NCT07348471 — Fecal Microbiota Transplantation for the Treatment of ICU Delirium · NA · recruiting
- NCT06969287 — Mitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery · Phase 3 · recruiting
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- NCT07488468 — Quality Improvement Project to Reduce Preoperative Fasting Times Before Elective Procedures · recruiting
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Other University of Kansas Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04635774 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Kansas Medical Center
- Last refreshed: 21 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04635774.
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