NCT05382598|Completed
Timing of Renal Replacement Therapy In Mechanically Ventilated Patients
Early Versus Late Renal Replacement Therapy In Mechanically Ventilated Patients With Acute Kidney Injury
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Early Versus Late Renal Replacement Therapy In Mechanically Ventilated Patients With Acute Kidney Injury
Sponsor study identifier
interventional
94
1 country
1
Study Start
June 28, 2022
Actual (reported)Primary Completion
November 20, 2023
Actual (reported)Study Completion
November 28, 2023
Actual (reported)This is a randomized controlled study that will be conducted on acute kidney injury (AKI) patients, who are mechanically ventilated, to assess the impact of implementation of early renal replacement therapy (RRT) compared to late RRT on patients outcome.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 28, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 17, 2022
Actual (reported)May 19, 2022
Actual (reported)June 28, 2022
Actual (reported)November 20, 2023
Actual (reported)November 28, 2023
Actual (reported)mortality
ICU mortality
28 days
ICU length of stay
Duration of ICU stay
through study completion, an average of 1 year
Weaning of mechanical ventilation
duration of mechanical ventilation
through study completion, an average of 1 year
RRT dependency
for more than three months
Renal functions on discharge from ICU
through study completion, an average of 1 year
In this group of patients, RRT will be initiated if the patient either presents with or develops AKI, while mechanically ventilated, provided that he is in stage 2 according to KDIGO classification. RRT will not be delayed till the presence of an urgent indication for the procedure. A trial of furosemide stress test will be applied before proceeding towards early RRT after volume optimization.
This group of patients will receive RRT if they develop any of the following indications: * Severe hyperkalemia (\> 6.5 mEq/L). * Oliguria with failed response to diuretics in the presence of life-threatening pulmonary edema requiring high ventilatory settings i.e. PEEP \>10 in addition to FiO2 \> 50%. * Severe metabolic acidosis (PH \<7.15). * Uremic pericarditis, encephalopathy or coagulopathy.
Renal replacement therapy (RRT) will be initiated in the early group for patients who have stage 2 AKI according to KDIGO classification. The late group will have RRT when they develop any of the absolute indications for RRT
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Alexandria Faculty of Medicine
Alexandria, Alexandria Governorate, 21131, Egypt
Thomas ME, Blaine C, Dawnay A, Devonald MA, Ftouh S, Laing C, Latchem S, Lewington A, Milford DV, Ostermann M. The definition of acute kidney injury and its use in practice. Kidney Int. 2015 Jan;87(1):62-73. doi: 10.1038/ki.2014.328. Epub 2014 Oct 15.
Kellum JA, Lameire N, Aspelin P, Barsoum RS, Burdmann EA, Goldstein SL, et al. Kidney disease: Improving global outcomes (KDIGO) acute kidney injury work group. KDIGO clinical practice guideline for acute kidney injury. Kidney Int Suppl 2012;2:1-138
Kidney Disease: Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO 2021 Clinical Practice Guideline for the Management of Blood Pressure in Chronic Kidney Disease. Kidney Int. 2021 Mar;99(3S):S1-S87. doi: 10.1016/j.kint.2020.11.003. No abstract available.
Amr M Elsharkawy, Master
Alexandria Faculty of Medicine
94 participants (actual enrollment reported by the registry).
First Submitted
April 17, 2022
First Posted
May 19, 2022
Study Start
June 28, 2022
Actual (reported)Early RRT in AKI After Cardiac Surgery
Contact the study team to confirm eligibility.
Gaudry S, Hajage D, Benichou N, Chaibi K, Barbar S, Zarbock A, Lumlertgul N, Wald R, Bagshaw SM, Srisawat N, Combes A, Geri G, Jamale T, Dechartres A, Quenot JP, Dreyfuss D. Delayed versus early initiation of renal replacement therapy for severe acute kidney injury: a systematic review and individual patient data meta-analysis of randomised clinical trials. Lancet. 2020 May 9;395(10235):1506-1515. doi: 10.1016/S0140-6736(20)30531-6. Epub 2020 Apr 23.
Wald R, Bagshaw SM. The timing of renal replacement therapy initiation in acute kidney injury: is earlier truly better?*. Crit Care Med. 2014 Aug;42(8):1933-4. doi: 10.1097/CCM.0000000000000432. No abstract available.
Besen BAMP, Romano TG, Mendes PV, Gallo CA, Zampieri FG, Nassar AP Jr, Park M. Early Versus Late Initiation of Renal Replacement Therapy in Critically Ill Patients: Systematic Review and Meta-Analysis. J Intensive Care Med. 2019 Sep;34(9):714-722. doi: 10.1177/0885066617710914. Epub 2017 Jun 1.
Yang XM, Tu GW, Zheng JL, Shen B, Ma GG, Hao GW, Gao J, Luo Z. A comparison of early versus late initiation of renal replacement therapy for acute kidney injury in critically ill patients: an updated systematic review and meta-analysis of randomized controlled trials. BMC Nephrol. 2017 Aug 7;18(1):264. doi: 10.1186/s12882-017-0667-6.
Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.
Stawicki SP, Braslow BM, Panebianco NL, Kirkpatrick JN, Gracias VH, Hayden GE, Dean AJ. Intensivist use of hand-carried ultrasonography to measure IVC collapsibility in estimating intravascular volume status: correlations with CVP. J Am Coll Surg. 2009 Jul;209(1):55-61. doi: 10.1016/j.jamcollsurg.2009.02.062. Epub 2009 May 1.
Bersten AD, Handy JM. Oh's intensive care manual. 8th ed. Oxford, U.K.: Elsevier; 2018.
Fink MP, Vincent JL, Abraham E, Moore FA, Kochanek P. Textbook of critical care. 7th ed. Philadelphia, PA: Elsevier; 2016.
Turner N, Lameire N, Goldsmith DJ, Winearls CG, Himmelfarb J, Remuzzi G. Oxford textbook of clinical nephrology. 4th ed. Oxford, United Kingdom: Oxford University Press; 2016.
Goldsmith D, Jayawardene S, Ackland P. ABC of kidney disease. 2nd ed. United Kingdom : BMJ Books; 2013.
Primary Completion
November 20, 2023
Actual (reported)Study Completion
November 28, 2023
Actual (reported)Last Updated
December 4, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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