The Effect of Dexmedetomidine on the Renal Functions in Septic Critically Ill Patients

Summary

This clinical trial aims to evaluate the effect of dexmedetomidine in Sepsis-Associated Acute Kidney Injury in critically ill patients by answering the following questions: 1. What is dexmedetomidine's effect on kidney functions? 2. What is the safety and efficacy of dexmedetomidine in Sepsis-Associated Acute Kidney Injury? The investigator will compare dexmedetomidine to the standard sedative. The Participant will take either dexmedetomidine or the standard sedative during their hospitalization, with follow-up of the following: 1. Vital signs including blood pressure, body temperature, respiratory rate, heart rate, and oxygen saturation. 2. Laboratory data including kidney function tests, electrolytes, complete blood count, and liver function tests. 3. An electrocardiogram will be followed to check the heart's electrical activity. 4. The level of alertness or agitation to avoid over and under-sedation. 5. The level of organ dysfunction and mortality risks. 6. Duration of mechanical ventilation. 7. Duration of hospitalization.

Timeline

Start

2024-10-01

Primary completion

2026-10

Completion

2026-10

Publications

• Background 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. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
• Background Manrique-Caballero CL, Del Rio-Pertuz G, Gomez H. Sepsis-Associated Acute Kidney Injury. Crit Care Clin. 2021 Apr;37(2):279-301. doi: 10.1016/j.ccc.2020.11.010. Epub 2021 Feb 13.
• Background Cobussen M, Verhave JC, Buijs J, Stassen PM. The incidence and outcome of AKI in patients with sepsis in the emergency department applying different definitions of AKI and sepsis. Int Urol Nephrol. 2023 Jan;55(1):183-190. doi: 10.1007/s11255-022-03267-5. Epub 2022 Jul 20.
• Background Zarbock A, Koyner JL, Gomez H, Pickkers P, Forni L; Acute Disease Quality Initiative group. Sepsis-associated acute kidney injury-treatment standard. Nephrol Dial Transplant. 2023 Dec 20;39(1):26-35. doi: 10.1093/ndt/gfad142.
• Background Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
• Background Bao N, Tang B. Organ-Protective Effects and the Underlying Mechanism of Dexmedetomidine. Mediators Inflamm. 2020 May 9;2020:6136105. doi: 10.1155/2020/6136105. eCollection 2020.
• Background Heybati K, Zhou F, Ali S, Deng J, Mohananey D, Villablanca P, Ramakrishna H. Outcomes of dexmedetomidine versus propofol sedation in critically ill adults requiring mechanical ventilation: a systematic review and meta-analysis of randomised controlled trials. Br J Anaesth. 2022 Oct;129(4):515-526. doi: 10.1016/j.bja.2022.06.020. Epub 2022 Aug 10.
• Background Hu H, An S, Sha T, Wu F, Jin Y, Li L, Zeng Z, Wu J, Chen Z. Association between dexmedetomidine administration and outcomes in critically ill patients with sepsis-associated acute kidney injury. J Clin Anesth. 2022 Dec;83:110960. doi: 10.1016/j.jclinane.2022.110960. Epub 2022 Oct 19.
• Background Cioccari L, Luethi N, Bailey M, Shehabi Y, Howe B, Messmer AS, Proimos HK, Peck L, Young H, Eastwood GM, Merz TM, Takala J, Jakob SM, Bellomo R; ANZICS Clinical Trials Group and the SPICE III Investigators. The effect of dexmedetomidine on vasopressor requirements in patients with septic shock: a subgroup analysis of the Sedation Practice in Intensive Care Evaluation [SPICE III] Trial. Crit Care. 2020 Jul 16;24(1):441. doi: 10.1186/s13054-020-03115-x.
• Background Duff S, Murray PT. Defining Early Recovery of Acute Kidney Injury. Clin J Am Soc Nephrol. 2020 Sep 7;15(9):1358-1360. doi: 10.2215/CJN.13381019. Epub 2020 Apr 1. No abstract available.
• Background Mehta RL. Renal Recovery After Acute Kidney Injury and Long-term Outcomes: Is Time of the Essence? JAMA Netw Open. 2020 Apr 1;3(4):e202676. doi: 10.1001/jamanetworkopen.2020.2676. No abstract available.
• Background Bai Y, Li Y, Jin J, Cheng M, Zhang S, Yang X, Xu J. Effects of early recovery of renal function on adverse renal outcomes and mortality in patients with acute kidney injury: a systematic review and meta-analysis. Int Urol Nephrol. 2024 Jul;56(7):2421-2430. doi: 10.1007/s11255-024-03974-1. Epub 2024 Mar 7.
• Background Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.
• Background Hughes CG, Mailloux PT, Devlin JW, Swan JT, Sanders RD, Anzueto A, Jackson JC, Hoskins AS, Pun BT, Orun OM, Raman R, Stollings JL, Kiehl AL, Duprey MS, Bui LN, O'Neal HR Jr, Snyder A, Gropper MA, Guntupalli KK, Stashenko GJ, Patel MB, Brummel NE, Girard TD, Dittus RS, Bernard GR, Ely EW, Pandharipande PP; MENDS2 Study Investigators. Dexmedetomidine or Propofol for Sedation in Mechanically Ventilated Adults with Sepsis. N Engl J Med. 2021 Apr 15;384(15):1424-1436. doi: 10.1056/NEJMoa2024922. Epub 2021 Feb 2.

Drugs

Indications