NCT03175328: CRTSAKI

CRRT Timing in Sepsis-associated AKI in ICU

Status unknown NA Last updated 22 December 2021

What this trial tests

NA trial testing continuous renal replacement therapies in Sepsis-Associated Organ Dysfunction in 460 participants. Status unknown.

Timeline

22 August 2019

Primary endpoint
21 August 2023

21 August 2024

Quick facts

Lead sponsor	Second Affiliated Hospital of Guangzhou Medical University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	460
Start date	22 August 2019
Primary completion	21 August 2023
Estimated completion	21 August 2024
Sites	2 locations across China

Drugs / interventions tested

• continuous renal replacement therapies

Conditions studied

• Sepsis-Associated Organ Dysfunction — all drugs for Sepsis-Associated Organ Dysfunction →
• RTT — all drugs for RTT →

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Who can join

Adults 18 to 90, any sex, with Sepsis-Associated Organ Dysfunction or RTT. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Perioperative Acute Kidney Injury.
   Gumbert SD, Kork F, Jackson ML, Vanga N, et al · · 2020 · cited 209× · PMID 31687986 · DOI 10.1097/aln.0000000000002968
2. 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.
   Chen WY, Cai LH, Zhang ZH, Tao LL, et al · · 2021 · cited 19× · PMID 33608398 · DOI 10.1136/bmjopen-2020-040718
3. Comprehensive Management of Blood Pressure in Patients with Septic AKI.
   Deng J, Li L, Feng Y, Yang J. · · 2023 · cited 11× · PMID 36769666 · DOI 10.3390/jcm12031018