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NCT03331146
Nitrite Infusion in High Risk Patients Undergoing Cardiopulmonary Bypass
Phase 3 trial testing Saline in Acute Kidney Injury. Withdrawn.
1 June 2019
Quick facts
| Lead sponsor | University of Alabama at Birmingham |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Start date | 1 October 2018 |
| Primary completion | 1 June 2019 |
| Estimated completion | 1 December 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Saline
- Sodium Nitrite (SODIUM NITRITE) — full drug profile →
Conditions studied
- Acute Kidney Injury — all drugs for Acute Kidney Injury →
Sponsor
University of Alabama at Birmingham
Who can join
Adults 19 to 100, any sex, with Acute Kidney Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objective of this study is to evaluate the efficacy of intravenous sodium nitrite compared with placebo in reducing the occurrence of CSA-AK as diagnosed by KDIGO criteria during the first 72 hrs after cardiac surgery in high-risk patients undergoing cardiac surgery. Secondary objectives are to determine whether IV sodium nitrite achieves adequate pharmacokinetics (PK) in patients undergoing cardiac surgery with the use of CPB.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Perioperative Acute Kidney Injury.
Gumbert SD, Kork F, Jackson ML, Vanga N, et al · · 2020 · cited 209× · PMID 31687986 · DOI 10.1097/aln.0000000000002968
Verify or expand the search:
- PubMed search for NCT03331146
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Acute Kidney Injury
Currently open trials in the same condition.
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Other University of Alabama at Birmingham 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 NCT03331146 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- 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 Alabama at Birmingham
- Last refreshed: 27 September 2018
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/NCT03331146.
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