Timing of Renal Replacement Therapy In Mechanically Ventilated Patients

NCT05382598 | Completed

• 1 other identifier: 4220
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Timing of RRT in Mechanically Ventilated Patients

Keywords

early and late RRT; AKI; Mechanical ventilation

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• RRT dependency

  for more than three months

• Renal functions on discharge from ICU

  through study completion, an average of 1 year

Study Arms (2)

Early renal replacement therapy (RRT) group

ACTIVE COMPARATOR

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.

Procedure: Renal replacement therapy

Late renal replacement therapy (RRT) group

ACTIVE COMPARATOR

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.

Procedure: Renal replacement therapy

Interventions

Renal replacement therapy PROCEDURE

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

Early renal replacement therapy (RRT) group; Late renal replacement therapy (RRT) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must be on invasive mechanical ventilation.
• Patients in AKI stage 2 , according to KDIGO classification.
• Recruited subjects will include either those who present with AKI on their ICU admission or those who develop AKI during their ICU stay

You may not qualify if:

• Those who are known to be in grade 5 CKD according to KDIGO classification. All other grades of CKD from 1 to 4 will be included only if they develop or present with stage 2 AKI on top of their CKD grade
• Those who develop AKI due to obstructive or traumatic causes.
• Patients with septic shock who are on high doses of vasopressors or inotropes (norepinephrine infusion more than 1 mcg/kg/minute, dopamine or dobutamine infusion more than 5 mcg/kg/minute).
• Pregnant females

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, Alexandria Governorate, 21131, Egypt

Location

Related Publications (13)

• 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.

  PMID: 25317932 RESULT

• 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

  RESULT

• 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.

  PMID: 33637192 RESULT

• 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.

  PMID: 32334654 RESULT

• 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.

  PMID: 25029128 RESULT

• 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.

  PMID: 28569129 RESULT

• 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.

  PMID: 28784106 RESULT

• 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.

  PMID: 24053972 RESULT

• 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.

  PMID: 19651063 RESULT

• Bersten AD, Handy JM. Oh's intensive care manual. 8th ed. Oxford, U.K.: Elsevier; 2018.

  RESULT

• Fink MP, Vincent JL, Abraham E, Moore FA, Kochanek P. Textbook of critical care. 7th ed. Philadelphia, PA: Elsevier; 2016.

  RESULT

• 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.

  RESULT

• Goldsmith D, Jayawardene S, Ackland P. ABC of kidney disease. 2nd ed. United Kingdom : BMJ Books; 2013.

  RESULT

MeSH Terms

Interventions

Renal Replacement Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Amr M Elsharkawy, Master

  Alexandria Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: May 19, 2022
• Study Start: June 28, 2022
• Primary Completion: November 20, 2023
• Study Completion: November 28, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)