CRRT Timing in Sepsis-associated AKI in ICU

NCT03175328 | Unknown DMC

• 1 other identifier: ICU-01
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 2

Brief Summary

Sepsis continues to be a major global cause of both mortality and morbidity. Furthermore, the development of acute kidney injury (AKI) in sepsis increases the risk of unfavorable outcomes. Besides source control, fluid resuscitation and the use of antibiotics, application of extracorporeal renal replacement therapies (RRT) is the predominant treatment for sepsis-associated AKI (SAKI). However, the timing of initiation of RRT remains controversial. It is reported that a correlation was observed between the concentrations of circulating inflammatory cytokines and mortality in patients with septic shock. Therefore, it is hypothesis that adequate removal of inflammatory mediators from the circulation may provide a potential therapy for this devastating condition. Indeed, data from meta-analyses, observational studies and randomized controlled trial (RCT) suggests that initiating RRT in critical ill patients (including patients with sepsis and non-sepsis) at early stage may be beneficial. But in some studies, initiating RRT at early stage do not shown to improve survival compared with initiating RRT at late stage. At present, large-scale prospective RCT about the timing for initiating RRT in SAKI was still lack.The decision when to start RRT is not merely academic but may impact on outcomes. Therefore, in our study, 460 patients with SAKI at KDIGO 2 from multicenter in China will be recruited. And then the patients will be divided into early group and delayed group randomly. In the early group, continuous RRT (CRRT) was started immediately after randomization. In the delay group, CRRT was initiated if at least one of the following criteria was met: KDIGO 3, severe hyperkalemia, pulmonary edema, blood urea nitrogen level higher than 112 mg per deciliter after randomization. Overall survival at day 90 will be observed in order to understand whether different CRRT strategy would affect the outcomes of SAKI. This clinical study will be a large-scale, multi center, prospective, randomized trial about SAKI. It will help clinician choose appropriate timing to initiate CRRT and improve outcomes of SAKI.

Conditions

Sepsis-Associated Organ Dysfunction; RTT

Outcome Measures

Primary Outcomes (1)

• overall mortality

  overall survival measured from randomization to death or day 90

  90 days

Secondary Outcomes (7)

• recovery rate of renal function

  90 days

• organ dysfunction

  90 days

• length of ICU stay and in-hospital stay

  90 days

• the percentage of receipt of CRRT at least once in the delayed group

  90 days

• the number of days alive without CRRT, mechanical ventilation and vasopressor

  90 days

Study Arms (2)

early group

EXPERIMENTAL

In the early group, continuous renal replacement therapies was started within 8 hours after randomization.

Procedure: continuous renal replacement therapies

delayed group

EXPERIMENTAL

In the delayed group, continuous renal replacement therapies was initiated if at least one of the following criteria was met: KDIGO 3, severe hyperkalemia, pulmonary edema, blood urea nitrogen level higher than 112 mg per deciliter after randomization.

Procedure: continuous renal replacement therapies

Interventions

continuous renal replacement therapies PROCEDURE

The choice of the method of continuous renal replacement therapy (device setting and anticoagulation method) is left to the discretion of each study site and was prescribed and monitored according to national guidelines.

delayed group; early group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 90 years.
• Patients admitted into ICU with Sepsis (sepsis-3) compatible with the diagnosis of AKI at stage 2 of KDIGO classification.
• Informed consent provided by the patient or person with decisional responsibility.

You may not qualify if:

• \. Presence of one of the emergent CRRT conditions before randomization:
• Hyperkalemia \> 6.0 mmol/L or \> 5.5 mmol/L persisting despite medical treatment.
• Acute pulmonary edema due to fluid overload responsible for severe hypoxemia requiring oxygen flow rate \> 5 L/min to maintain a percutaneous oxygen saturation (SpO2) \> 95% or a fraction of inspiration oxygen (FiO2) \> 50% in patients already on invasive or non-invasive mechanical ventilation and despite diuretic therapy.
• Blood urea nitrogen (BUN) \> 112 mg/dl (40 mmol/L). 2. Pre-existing severe chronic renal failure \[estimated glomerular filtration rate (eGFR) \< 30 ml/min\].
• \. Previous renal replacement therapy. 4. Prior kidney t

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (2)

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

Related Publications (2)

• Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.

  PMID: 36416787 DERIVED

• Chen WY, Cai LH, Zhang ZH, Tao LL, Wen YC, Li ZB, Li L, Ling Y, Li JW, Xing R, Liu XY, Lin ZD, Deng ZT, Wang SH, Lin QH, Zhou DR, He ZJ, Xiong XM. The timing of continuous renal replacement therapy initiation in sepsis-associated acute kidney injury in the intensive care unit: the CRTSAKI Study (Continuous RRT Timing in Sepsis-associated AKI in ICU): study protocol for a multicentre, randomised controlled trial. BMJ Open. 2021 Feb 19;11(2):e040718. doi: 10.1136/bmjopen-2020-040718.

  PMID: 33608398 DERIVED

Study Officials

• Xu-ming Xiong, PHD

  Second Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Xu-ming Xiong

CONTACT

+86 20 34152225; xiongxuming9@126.com

Wei-yan Chen, MD

CONTACT

+86 20 34153246; sam11124@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 5, 2017
• Study Start: August 22, 2019
• Primary Completion: August 21, 2023
• Study Completion: August 21, 2024
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)