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CRRT Timing in Sepsis-associated AKI in ICU

NCT ID: NCT03175328

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

460 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2024-08-21

Brief Summary

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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.

Detailed Description

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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, 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.

Conditions

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Sepsis-Associated Organ Dysfunction RTT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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early group

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

Group Type EXPERIMENTAL

continuous renal replacement therapies

Intervention Type 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

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.

Group Type EXPERIMENTAL

continuous renal replacement therapies

Intervention Type 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.

Interventions

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continuous renal replacement therapies

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1\. Presence of one of the emergent CRRT conditions before randomization:

1. Hyperkalemia \> 6.0 mmol/L or \> 5.5 mmol/L persisting despite medical treatment.
2. 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.
3. Blood urea nitrogen (BUN) \> 112 mg/dl (40 mmol/L). 2. Pre-existing severe chronic renal failure \[estimated glomerular filtration rate (eGFR) \< 30 ml/min\].

3\. Previous renal replacement therapy. 4. Prior kidney t
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xu-ming Xiong, PHD

Role: STUDY_DIRECTOR

Second Affiliated Hospital of Guangzhou Medical University

Locations

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the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xu-ming Xiong

Role: CONTACT

Phone: +86 20 34152225

Email: [email protected]

Wei-yan Chen, MD

Role: CONTACT

Phone: +86 20 34153246

Email: [email protected]

Facility Contacts

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Shi-kun Qian, MD

Role: primary

Xu-ming Xiong, PHD

Role: primary

Wei-yan Chen, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 36416787 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33608398 (View on PubMed)

Other Identifiers

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ICU-01

Identifier Type: -

Identifier Source: org_study_id