To Explore the Influence of CRRT Nursing Team Management Plan on the Prognosis of SAKI PatientsNCT06083285
Impact of the CRRT Management Protocol on Prognostic Outcome in Patients With Septic Acute Kidney Injury
An observational study of To Explore the Influence of CRRT Nursing Team Management Plan on the Prognosis of SAKI Patients, run by Xinjiang Medical University at 1 site in China.
Trial summary
The implementation of CRRT nursing team management program in the treatment of SAKI can significantly reduce the incidence of adverse events and complications in CRRT nursing, which has a positive role in improving the success rate of CRRT treatment and the clinical outcome of patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- To Explore the Influence of CRRT Nursing Team Management Plan on the Prognosis of SAKI Patients
- What is being tested?
- Implement the CRRT specialist nursing group management program on the basis of routine care
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 7 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 36 SAKI patients who were treated with CRRT in ICU of our hospital from February 2021 to August 2021 were set as the control group, and the routine bedside CRRT nursing management process was implemented in this stage; In addition, from September 2021 to March 2022, 40 SAKI patients who received CRRT treatment in our ICU were set as the observation group.The management plan of CRRT special nursing team was implemented to compare the incidence of non planned removal of CRRT, unplanned extubation and CRRT nursing related complications between the two groups, as well as the difference of coagulation function indexes before and 3 days after nursing.
Who may be able to join
- The Guidelines for Emergency Treatment of Sepsis / Septic Shock in China (2018)[4]Diagnostic criteria for moderate sepsis; ② meets the Organization for Improving Global Kidney Disease Outcomes (KDIGO) Clinical Practice Guidelines: AKI[5]Relevant diagnostic criteria in; ③ received CRRT as indicated for CRRT; ④ in ICU for longer than 24 hours; ⑤ signed consent.
Who cannot join
- with chronic organ failure, or advanced malignancy; ② with previous history of chronic kidney disease, retrorenal urinary tract obstruction; ③ with incomplete clinical data.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinjiang Medical University of Affiliated tumour Hospital
Ürümqi, Xinjiang, 830011
About this study
Official title: Xinjiang Medical University of Affiliated Tumour Hospital
The implementation of CRRT nursing team management program in the treatment of SAKI can significantly reduce the incidence of adverse events and complications in CRRT nursing, which has a positive role in improving the success rate of CRRT treatment and the clinical outcome of patients.
- Conditions
- To Explore the Influence of CRRT Nursing Team Management Plan on the Prognosis of SAKI Patients
- Being tested
- Implement the CRRT specialist nursing group management program on the basis of routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implement the CRRT specialist nursing group management program on the basis of routine careOther
Training the department nurses on CRRT related theoretical knowledge and operation skills; guiding the process of CRRT different treatment modes, solving CRRT nursing problems, evidence-based nursing guidance; consulting CRRT treatment and nursing related treatment, timely understanding the new progress; responsible for CRRT nursing quality control, etc.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Not described | |
| Observation group | Not described Receives: Other: Implement the CRRT specialist nursing group management program on the basis of routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the influence of CRRT nursing team management plan on the prognosis of SAKI patients.
The incidence of unplanned removal of CRRT, unplanned extubation and CRRT nursing related complications in the observation group were lower than those in the control group (P <0.05). Kaplan Meier survival curve showed that the survival rate of patients in the observation group was higher than that in the control group (P <0.05).
Measured: 3-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Feb 2021
- Primary completion1 May 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Explore the Influence of CRRT Nursing Team Management Plan on the Prognosis of SAKI PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiemuziya Maimaitirexiati, Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083285
- Sponsor's protocol ID
- XMaimaitirexiati
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xinjiang Medical University of Affiliated Tumour Hospital
- ClinicalTrials.gov ID
- NCT06083285
- Acronym / sponsor ID
- XMaimaitirexiati
- Conditions
- To Explore the Influence of CRRT Nursing Team Management Plan on the Prognosis of SAKI Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Xinjiang Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The implementation of CRRT nursing team management program in the treatment of SAKI can significantly reduce the incidence of adverse events and complications in CRRT nursing, which has a positive role in improving the success rate of CRRT treatment and the clinical outcome of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | – |
| Observation group | – | Other: Implement the CRRT specialist nursing group management program on the basis of routine care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 36 SAKI patients who were treated with CRRT in ICU of our hospital from February 2021 to August 2021 were set as the control group, and the routine bedside CRRT nursing management process was implemented in this stage; In addition, from September 2021 to March 2022, 40 SAKI patients who received CRRT treatment in our ICU were set as the observation group.The management plan of CRRT special nursing team was implemented to compare the incidence of non planned removal of CRRT, unplanned extubation and CRRT nursing related complications between the two groups, as well as the difference of coagulation function indexes before and 3 days after nursing.
Key inclusion criteria (1 listed)
- The Guidelines for Emergency Treatment of Sepsis / Septic Shock in China (2018)[4]Diagnostic criteria for moderate sepsis; ② meets the Organization for Improving Global Kidney Disease Outcomes (KDIGO) Clinical Practice Guidelines: AKI[5]Relevant diagnostic criteria in; ③ received CRRT as indicated for CRRT; ④ in ICU for longer than 24 hours; ⑤ signed consent.
Key exclusion criteria (1 listed)
- with chronic organ failure, or advanced malignancy; ② with previous history of chronic kidney disease, retrorenal urinary tract obstruction; ③ with incomplete clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implement the CRRT specialist nursing group management program on the basis of routine careTraining the department nurses on CRRT related theoretical knowledge and operation skills; guiding the process of CRRT different treatment modes, solving CRRT nursing problems, evidence-based nursing guidance; consulting CRRT treatment and nursing related treatment, timely understanding the new progress; responsible for CRRT nursing quality control, etc. | Other | Observation group |
Primary outcome
To explore the influence of CRRT nursing team management plan on the prognosis of SAKI patients.
Time frame: 3-10 days
The incidence of unplanned removal of CRRT, unplanned extubation and CRRT nursing related complications in the observation group were lower than those in the control group (P <0.05). Kaplan Meier survival curve showed that the survival rate of patients in the observation group was higher than that in the control group (P <0.05).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Explore the Influence of CRRT Nursing Team Management Plan on the Prognosis of SAKI Patients, run by Xinjiang Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore the influence of CRRT nursing team management plan on the prognosis of SAKI patients. (time frame: 3-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.