Remote ischemic conditioning in septic shock: the RECO-Sepsis randomized clinical trial.


Journal

Intensive care medicine
ISSN: 1432-1238
Titre abrégé: Intensive Care Med
Pays: United States
ID NLM: 7704851

Informations de publication

Date de publication:
11 2022
Historique:
received: 31 05 2022
accepted: 18 08 2022
pubmed: 14 9 2022
medline: 27 10 2022
entrez: 13 9 2022
Statut: ppublish

Résumé

To determine whether remote ischemic conditioning (RECO), compared to standard care, limits the severity and the consequences of multiple organ failure in patients with septic shock. The RECO-Sepsis trial, a prospective, multicenter, randomized, open-label, parallel group trial with blinded assessment of the outcome, was conducted at six intensive care units in France in adult patients with septic shock. Within 12 h after the onset of septic shock, patients were randomized (1:1 ratio) to receive either RECO applied by inflating/deflating (200/0 mmHg for 5/5 min) 4 times a cuff around an arm or a sham procedure every 12 h for 24 h. The primary endpoint was the severity of multiple organ failure assessed by the mean daily Sequential Organ Failure Assessment (SOFA) score from inclusion to the fourth day after inclusion (day 4). Patients were followed for 90 days. Among 180 randomized patients, 178 completed the trial (RECO group: 87; control group: 91) and were included in the intention-to-treat analysis (108 men [60.7%], median age 68 [59-75] years). There was no significant difference in the mean daily SOFA score between the intervention group and the control group (7.2 points [5.2-10.7] versus 7.6 points [4.9-10.7], respectively; p = 0.919). Cumulative mortality within 90 days was 27.6% in the RECO group and 39.6% control group (Log-rank test, p = 0.10; adjusted hazard ratio 0.59, 95% CI, 0.35 to 0.99; p = 0.049). In patients with septic shock, RECO failed to reduce the severity of organ failures assessed by mean daily SOFA score from inclusion to day 4. Adequately powered trials are needed to assess potential delayed benefits of RECO.

Identifiants

pubmed: 36100725
doi: 10.1007/s00134-022-06872-1
pii: 10.1007/s00134-022-06872-1
doi:

Banques de données

ClinicalTrials.gov
['NCT03201575']

Types de publication

Randomized Controlled Trial Multicenter Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

1563-1572

Subventions

Organisme : French Ministry of Health
ID : PHRCI-2016

Investigateurs

Romain Hernu (R)
Inesse Gragueb-Chebib (I)
Thomas Baudry (T)
Thomas Madelaine (T)
Sonia Machado (S)
Boris Jung (B)
Elizabeth Coupez (E)
Alexandre Lautrette (A)
Auguste Dargent (A)
Nicolas Terzi (N)
Fabrice Zeni (F)
Guillaume Thiery (G)

Informations de copyright

© 2022. Springer-Verlag GmbH Germany, part of Springer Nature.

Références

Shankar-Hari M, Phillips GS, Levy ML, Seymour CW, Liu VX, Deutschman CS, Angus DC, Rubenfeld GD, Singer M, Force SDT (2016) Developing a new definition and assessing new clinical criteria for septic shock: for the third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA 315:775–787. https://doi.org/10.1001/jama.2016.0289
doi: 10.1001/jama.2016.0289 pubmed: 26903336 pmcid: 4910392
Vincent JL, Jones G, David S, Olariu E, Cadwell KK (2019) Frequency and mortality of septic shock in Europe and North America: a systematic review and meta-analysis. Crit Care 31(23):196. https://doi.org/10.1186/s13054-019-2478-6
doi: 10.1186/s13054-019-2478-6
Cecconi M, Evans L, Levy M, Rhodes A (2018) Sepsis and septic shock. Lancet 392:75–87. https://doi.org/10.1016/S0140-6736(18)30696-2
doi: 10.1016/S0140-6736(18)30696-2 pubmed: 29937192
Angus DC, van der Poll T (2013) Severe sepsis and septic shock. N Engl J Med 369:840–851. https://doi.org/10.1056/NEJMra1208623
doi: 10.1056/NEJMra1208623 pubmed: 23984731
De Backer D, Cecconi M, Lipman J, Machado F, Myatra SN, Ostermann M, Perner A, Teboul JL, Vincent JL, Walley KR (2019) Challenges in the management of septic shock: a narrative review. Intensive Care Med 45:420–433. https://doi.org/10.1007/s00134-019-05544-x
doi: 10.1007/s00134-019-05544-x pubmed: 30741328
Kloner RA, Shi J, Dai W, Carreno J, Zhao L (2020) Remote ischemic conditioning in acute myocardial infarction and shock states. J Cardiovasc Pharmacol Ther 25:103–109. https://doi.org/10.1177/1074248419892603
doi: 10.1177/1074248419892603 pubmed: 31823646
Cour M, Lecour S (2019) Remote ischaemic conditioning: in search of a suitable match. Nat Rev Cardiol 16:704–705. https://doi.org/10.1038/s41569-019-0296-9
doi: 10.1038/s41569-019-0296-9 pubmed: 31591536
Hausenloy DJ (2016) Yellon DM (2016) Ischaemic conditioning and reperfusion injury. Nat Rev Cardiol 13:193–209. https://doi.org/10.1038/nrcardio.2016.5
doi: 10.1038/nrcardio.2016.5 pubmed: 26843289
Ho AFW, Chong J, Ong MEH, Hausenloy DJ (2020) Remote ischemic conditioning in emergency medicine—clinical frontiers and research opportunities. Shock 53:269–276. https://doi.org/10.1097/SHK.0000000000001362
doi: 10.1097/SHK.0000000000001362 pubmed: 32045394
Zhou D, Ding J, Ya J, Pan L, Wang Y, Ji X, Meng R (2018) Remote ischemic conditioning: a promising therapeutic intervention for multi-organ protection. Aging 10:1825–1855. https://doi.org/10.18632/aging.101527
doi: 10.18632/aging.101527 pubmed: 30115811 pmcid: 6128414
Pearce L, Davidson SM, Yellon DM (2021) Does remote ischaemic conditioning reduce inflammation? A focus on innate immunity and cytokine response. Basic Res Cardiol 116:12. https://doi.org/10.1007/s00395-021-00852-0
doi: 10.1007/s00395-021-00852-0 pubmed: 33629195 pmcid: 7904035
Gaspar A, Lourenço AP, Pereira MÁ, Azevedo P, Roncon-Albuquerque R Jr, Marques J, Leite-Moreira AF (2018) Randomized controlled trial of remote ischaemic conditioning in ST-elevation myocardial infarction as adjuvant to primary angioplasty (RIC-STEMI). Basic Res Cardiol 113:14. https://doi.org/10.1007/s00395-018-0672-3
doi: 10.1007/s00395-018-0672-3 pubmed: 29516192
Sloth AD, Schmidt MR, Munk K, Kharbanda RK, Redington AN, Schmidt M, Pedersen L, Sørensen HT, Bøtker HE, Investigators CONDI (2014) Improved long-term clinical outcomes in patients with ST-elevation myocardial infarction undergoing remote ischaemic conditioning as an adjunct to primary percutaneous coronary intervention. Eur Heart J 35:168–175. https://doi.org/10.1093/eurheartj/eht369
doi: 10.1093/eurheartj/eht369 pubmed: 24031025
Thielmann M, Kottenberg E, Kleinbongard P, Wendt D, Gedik N, Pasa S, Price V, Tsagakis K, Neuhäuser M, Peters J, Jakob H, Heusch G (2013) Cardioprotective and prognostic effects of remote ischaemic preconditioning in patients undergoing coronary artery bypass surgery: a single-centre randomised, double-blind, controlled trial. Lancet 382:597–604. https://doi.org/10.1016/S0140-6736(13)61450-6
doi: 10.1016/S0140-6736(13)61450-6 pubmed: 23953384
Kim YH, Yoon DW, Kim JH, Lee JH, Lim CH (2014) Effect of remote ischemic post-conditioning on systemic inflammatory response and survival rate in lipopolysaccharide-induced systemic inflammation model. J Inflamm 11:16. https://doi.org/10.1186/1476-9255-11-16
doi: 10.1186/1476-9255-11-16
Orbegozo Cortés D, Su F, Santacruz C, Hosokawa K, Donadello K, Creteur J, De Backer D, Vincent JL (2016) Ischemic conditioning protects the microcirculation, preserves organ function, and prolongs survival in sepsis. Shock 45:419–427. https://doi.org/10.1097/SHK.0000000000000526
doi: 10.1097/SHK.0000000000000526 pubmed: 26863119
Joseph B, Khalil M, Hashmi A, Hecker L, Kulvatunyou N, Tang A, Friese RS, Rhee P (2017) Survival benefits of remote ischemic conditioning in sepsis. J Surg Res 213:131–137. https://doi.org/10.1016/j.jss.2016.01.033
doi: 10.1016/j.jss.2016.01.033 pubmed: 28601305
Honda T, He Q, Wang F, Redington AN (2019) Acute and chronic remote ischemic conditioning attenuate septic cardiomyopathy, improve cardiac output, protect systemic organs, and improve mortality in a lipopolysaccharide-induced sepsis model. Basic Res Cardiol 114:15. https://doi.org/10.1007/s00395-019-0724-3
doi: 10.1007/s00395-019-0724-3 pubmed: 30838474
Kiudulaite I, Belousoviene E, Vitkauskiene A, Pranskunas A (2021) Effects of remote ischemic conditioning on microcirculatory alterations in patients with sepsis: a single-arm clinical trial. Ann Intensive Care 11:55. https://doi.org/10.1186/s13613-021-00848-y
doi: 10.1186/s13613-021-00848-y pubmed: 33829305 pmcid: 8025901
Cour M, Buisson M, Klouche K, Bouzgarrou R, Schwebel C, Quenot JP, Zeni F, Beuret P, Ovize M, Argaud L (2019) Remote ischemic conditioning in septic shock (RECO-Sepsis): study protocol for a randomized controlled trial. Trials 20:281. https://doi.org/10.1186/s13063-019-3406-4
doi: 10.1186/s13063-019-3406-4 pubmed: 31118101 pmcid: 6532140
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC (2016) The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA 315:801–810. https://doi.org/10.1001/jama.2016.0287
doi: 10.1001/jama.2016.0287 pubmed: 26903338 pmcid: 4968574
Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, Jones DW, Kurtz T, Sheps SG, Roccella EJ (2005) Recommendations for Blood Pressure Measurement in humans and experimental animals: part 1: blood pressure measurement in humans: a statement for professionals from the subcommittee of professional and public education of the American Heart Association council on high blood pressure Research. Circulation 111:697–716. https://doi.org/10.1161/01.CIR.0000154900.76284.F6
doi: 10.1161/01.CIR.0000154900.76284.F6 pubmed: 15699287
Rhodes A, Evans LE, Alhazzani W et al (2016) Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Intensive Care Med 43:304–377. https://doi.org/10.1007/s00134-017-4683-6
doi: 10.1007/s00134-017-4683-6
Le Gall JR, Lemeshow S, Saulnier F (1993) A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA 270:2957–2963. https://doi.org/10.1001/jama.270.24.2957
doi: 10.1001/jama.270.24.2957 pubmed: 8254858
Ferreira FL, Bota DP, Bross A, Mélot C, Vincent JL (2001) Serial evaluation of the SOFA Score to predict outcome in critically ill patients. JAMA 286:1754–1758. https://doi.org/10.1001/jama.286.14.1754
doi: 10.1001/jama.286.14.1754 pubmed: 11594901
Lambden S, Laterre PF, Levy MM, Francois B (2019) The SOFA score-development, utility and challenges of accurate assessment in clinical trials. Crit Care 23:374. https://doi.org/10.1186/s13054-019-2663-7
doi: 10.1186/s13054-019-2663-7 pubmed: 31775846 pmcid: 6880479
Zarbock A, Schmidt C, Van Aken H, Wempe C, Martens S, Zahn PK, Wolf B, Goebel U, Schwer CI, Rosenberger P, Haeberle H, Görlich D, Kellum JA, Meersch M, RenalRIPC Investigators (2015) Effect of remote ischemic preconditioning on kidney injury among high-risk patients undergoing cardiac surgery: a randomized clinical trial. JAMA 313:2133–2141. https://doi.org/10.1001/jama.2015.4189
doi: 10.1001/jama.2015.4189 pubmed: 26024502
Hu Q, Luo W, Huang L, Huang R, Chen R, Gao Y (2016) Multiorgan protection of remote ischemic perconditioning in valve replacement surgery. J Surg Res 200:13–20. https://doi.org/10.1016/j.jss.2015.06.053
doi: 10.1016/j.jss.2015.06.053 pubmed: 26205311
Wu J, Feng X, Huang H, Shou Z, Zhang X, Wang R, Chen Y, Chen J (2014) Remote ischemic conditioning enhanced the early recovery of renal function in recipients after kidney transplantation: a randomized controlled trial. J Surg Res 188:303–308. https://doi.org/10.1016/j.jss.2013.06.058
doi: 10.1016/j.jss.2013.06.058 pubmed: 24556231
de Grooth HJ, Geenen IL, Girbes AR, Vincent JL, Parienti JJ, Oudemans-van Straaten HM (2017) SOFA and mortality endpoints in randomized controlled trials: a systematic review and meta-regression analysis. Crit Care 21:38. https://doi.org/10.1186/s13054-017-1609-1
doi: 10.1186/s13054-017-1609-1 pubmed: 28231816 pmcid: 5324238
Gordon AC, Perkins GD, Singer M, McAuley DF, Orme RM, Santhakumaran S, Mason AJ, Cross M, Al-Beidh F, Best-Lane J, Brealey D, Nutt CL, McNamee JJ, Reschreiter H, Breen A, Liu KD, Ashby D (2016) Levosimendan for the prevention of acute organ dysfunction in sepsis. N Engl J Med 375:1638–1648. https://doi.org/10.1056/NEJMoa1609409
doi: 10.1056/NEJMoa1609409 pubmed: 27705084
Moskowitz A, Huang DT, Hou PC, Gong J, Doshi PB, Grossestreuer AV, Andersen LW, Ngo L, Sherwin RL, Berg KM, Chase M, Cocchi MN, McCannon JB, Hershey M, Hilewitz A, Korotun M, Becker LB, Otero RM, Uduman J, Sen A, Donnino MW, ACTS Clinical Trial Investigators (2020) Effect of ascorbic acid, corticosteroids, and thiamine on organ injury in septic shock: the ACTS randomized clinical trial. JAMA 324:642–650. https://doi.org/10.1001/jama.2020.11946
doi: 10.1001/jama.2020.11946 pubmed: 32809003 pmcid: 7435341
Fowler AA, Truwit JD, Hite RD et al (2019) Effect of vitamin C Infusion on organ failure and biomarkers of Inflammation and vascular injury in patients with sepsis and severe acute respiratory failure: the CITRIS-ALI randomized clinical trial. JAMA 322:1261–1270. https://doi.org/10.1001/jama.2019.11825
doi: 10.1001/jama.2019.11825 pubmed: 31573637 pmcid: 6777268

Auteurs

Martin Cour (M)

Médecine Intensive-Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, Service de Médecine Intensive-Réanimation, 5, Place d'Arsonval, 69437, Lyon Cedex 03, France. martin.cour@chu-lyon.fr.
Faculté de Médecine Lyon-Est, Université de Lyon, Lyon, France. martin.cour@chu-lyon.fr.

Kada Klouche (K)

Service de Médecine Intensive-Réanimation, CHU de Montpellier, Montpellier, France.

Bertrand Souweine (B)

Service de Médecine Intensive-Réanimation, CHU Gabriel Montpied, Clermont-Ferrand, France.

Jean-Pierre Quenot (JP)

Service de Médecine Intensive-Réanimation, CHU François-Mitterrand, Dijon, France.

Carole Schwebel (C)

Service de Médecine Intensive-Réanimation, CHU Albert Michallon, Grenoble, France.

Sophie Perinel (S)

Service de Médecine Intensive-Réanimation, CHU de Saint-Etienne, Saint-Etienne, France.

Camille Amaz (C)

Centre d'Investigations Cliniques (CIC), Hospices Civils de Lyon, Hôpital Cardiologique Louis Pradel, Bron, France.

Marielle Buisson (M)

Centre d'Investigations Cliniques (CIC), Hospices Civils de Lyon, Hôpital Cardiologique Louis Pradel, Bron, France.

Michel Ovize (M)

Faculté de Médecine Lyon-Est, Université de Lyon, Lyon, France.
Centre d'Investigations Cliniques (CIC), Hospices Civils de Lyon, Hôpital Cardiologique Louis Pradel, Bron, France.

Nathan Mewton (N)

Faculté de Médecine Lyon-Est, Université de Lyon, Lyon, France.
Centre d'Investigations Cliniques (CIC), Hospices Civils de Lyon, Hôpital Cardiologique Louis Pradel, Bron, France.

Laurent Argaud (L)

Médecine Intensive-Réanimation, Hospices Civils de Lyon, Hôpital Edouard Herriot, Service de Médecine Intensive-Réanimation, 5, Place d'Arsonval, 69437, Lyon Cedex 03, France.
Faculté de Médecine Lyon-Est, Université de Lyon, Lyon, France.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH