Postoperative glucocorticoids in patients with acute type A aortic dissection (GLAD) : study protocol for a prospective, single-center, randomized controlled trial
© 2023. The Author(s)..
BACKGROUND: Patients receiving surgical treatment of acute type A Aortic Dissection (aTAAD) are common to suffer organ dysfunction in the intensive care unit due to overwhelming inflammation. Previous studies have revealed that glucocorticoids may reduce complications in certain patient groups, but evidence between postoperative glucocorticoids administration and improvement in organ dysfunction after aTAAD surgery are lacking.
METHODS: This study will be an investigator-initiated, prospective, single-blind, randomized, single-center study. Subjects with confirmed diagnosis of aTAAD undergoing surgical treatment will be enrolled and 1:1 randomly assigned to receive either glucocorticoids or normal treatment. All patients in the glucocorticoids group will be given methylprednisolone intravenously for 3 days after enrollment. The primary endpoint will be the amplitude of variation of Sequential Organ Failure Assessment score on post-operative day 4 compared to baseline.
DISCUSSION: The trial will explore the rationale for postoperative application of glucocorticoids in patients after aTAAD surgery.
TRIAL REGISTRATION: This study has been registered on ClinicalTrials.gov (NCT04734418).
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
|---|---|
| Enthalten in: |
BMC anesthesiology - 23(2023), 1 vom: 15. Mai, Seite 164 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Deng, Yi-Zhi [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
Acute type A aortic dissection |
|---|
| Anmerkungen: |
Date Completed 17.05.2023 Date Revised 26.05.2023 published: Electronic ClinicalTrials.gov: NCT04734418 Citation Status MEDLINE |
|---|
| doi: |
10.1186/s12871-023-02124-x |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM356917363 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM356917363 | ||
| 003 | DE-627 | ||
| 005 | 20231226071456.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2023 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1186/s12871-023-02124-x |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1189.xml |
| 035 | |a (DE-627)NLM356917363 | ||
| 035 | |a (NLM)37189085 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Deng, Yi-Zhi |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Postoperative glucocorticoids in patients with acute type A aortic dissection (GLAD) |b study protocol for a prospective, single-center, randomized controlled trial |
| 264 | 1 | |c 2023 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 17.05.2023 | ||
| 500 | |a Date Revised 26.05.2023 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04734418 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a BACKGROUND: Patients receiving surgical treatment of acute type A Aortic Dissection (aTAAD) are common to suffer organ dysfunction in the intensive care unit due to overwhelming inflammation. Previous studies have revealed that glucocorticoids may reduce complications in certain patient groups, but evidence between postoperative glucocorticoids administration and improvement in organ dysfunction after aTAAD surgery are lacking | ||
| 520 | |a METHODS: This study will be an investigator-initiated, prospective, single-blind, randomized, single-center study. Subjects with confirmed diagnosis of aTAAD undergoing surgical treatment will be enrolled and 1:1 randomly assigned to receive either glucocorticoids or normal treatment. All patients in the glucocorticoids group will be given methylprednisolone intravenously for 3 days after enrollment. The primary endpoint will be the amplitude of variation of Sequential Organ Failure Assessment score on post-operative day 4 compared to baseline | ||
| 520 | |a DISCUSSION: The trial will explore the rationale for postoperative application of glucocorticoids in patients after aTAAD surgery | ||
| 520 | |a TRIAL REGISTRATION: This study has been registered on ClinicalTrials.gov (NCT04734418) | ||
| 650 | 4 | |a Clinical Trial Protocol | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Acute type A aortic dissection | |
| 650 | 4 | |a Glucocorticoid | |
| 650 | 4 | |a Methylprednisolone | |
| 650 | 4 | |a Organ dysfunction | |
| 650 | 7 | |a Glucocorticoids |2 NLM | |
| 700 | 1 | |a Luo, Ming-Hao |e verfasserin |4 aut | |
| 700 | 1 | |a Luo, Jing-Chao |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Jia-Kun |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Jia-Qi |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Yi-Jie |e verfasserin |4 aut | |
| 700 | 1 | |a Hou, Jun-Yi |e verfasserin |4 aut | |
| 700 | 1 | |a Su, Ying |e verfasserin |4 aut | |
| 700 | 1 | |a Tu, Guo-Wei |e verfasserin |4 aut | |
| 700 | 1 | |a Luo, Zhe |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t BMC anesthesiology |d 2001 |g 23(2023), 1 vom: 15. Mai, Seite 164 |w (DE-627)NLM116144939 |x 1471-2253 |7 nnns |
| 773 | 1 | 8 | |g volume:23 |g year:2023 |g number:1 |g day:15 |g month:05 |g pages:164 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1186/s12871-023-02124-x |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 23 |j 2023 |e 1 |b 15 |c 05 |h 164 | ||