Critical IllnessNCT04533100
The Association of Protein-Energy Adequacy With Mortality in Critically Ill Patients With Acute Kidney Injury.
An observational study of Critical Illness and Acute Kidney Injury, run by University of Malaya at 1 site in Malaysia.
Trial summary
This is a prospective observational single-center study in which the association of Protein-Energy Adequacy and 28-Days of Mortality among critically ill patients with Acute Kidney Injury, AKI will be investigated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Acute Kidney Injury
- How many people
- 185 participants
- Where
- 1 siteMalaysia
- Study dates
- 20 Jul 2020to Aug 2021
- How long will I take part?
- 28 Days
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be conducted in adult Intensive Care Unit, University Malaya Medical Centre (UMMC), Malaysia.
Who may be able to join
- Patients who are 18 years old and older
- Patients who are admitted to the participating ICU.
- Patients who are mechanically ventilated.
Who cannot join
- Patients who are less than 18 years old
- End-stage renal disease patients
- Patients undergo kidney transplantation within 3 months before ICU admission
- Pregnant patients
- The patient is moribund with expected death within 24 hour or whom survival to 28 days is unlikely due to uncontrollable comorbidity (cardiac, pulmonary or hepatic end-stage disease; hepatorenal syndrome; poorly controlled cancer; severe post-anoxic encephalopathy and others)
- Prior treatment with RRT within 30 days
- Anticipated alive ICU discharge within 24 hours
- Readmission to the ICU during the same hospitalization episode.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre
Kuala Lumpur, 59100
MOHD SHAHNAZ HASAN, MBBS, 0379493869 ext. 3869, shahnaz@ummc.edu.my
About this study
Official title: The Association of Protein-Energy Adequacy With Mortality in Critically Ill Patients With Acute Kidney Injury. A Prospective Observational Single- Centre Study.
This is a prospective observational single-center study in which the association of Protein-Energy Adequacy and 28-Days of Mortality among critically ill patients with Acute Kidney Injury, AKI will be investigated. The association of Protein-Energy adequacy with a length of ICU and hospital stay, total ventilator, and inotropic drug days among critically ill patients with AKI also will be investigated.
Read the detailed description
Patients with Acute Kidney Injury, AKI are probably more exposed to the risk of malnutrition especially if they undergo Renal Replacement Therapy, RRT. Optimization of nutrients especially energy and protein can ensure a better health outcome for critically ill patients with AKI. Moreover, there is no research on the association of Protein- Energy adequacy with mortality among critically ill patients with AKI in Malaysia. So, the main purpose of this study is to investigate the relationship of Protein-Energy adequacy with mortality among critically ill patients with AKI
Subjects will be recruited upon admission in ICU after fulfilling the inclusion and exclusion criteria. They will be follow up from day 1 until day 14 or until ICU Discharge. Data including Demographic, Clinical, Laboratory, and Nutritional Status will be recorded. On Day 28, the outcome data including Mortality, length of ICU Stay, and Length of Ventilator day will be recorded.
- Conditions
- Critical Illness, Acute Kidney Injury
- Keywords
- Protein, Energy, Adequacy, Mortality
- Medical subject headings
- Critical Illness, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
28-Days Mortality
Mortality status of subjects on day 28 from recruitment.
Measured: 1 day
Secondary outcomes (2)
Length of ICU Stay
Duration of ICU Stay from ICU admission until ICU discharge
Measured: 1 day
Length of Ventilator Day
Duration of ventilator used by subjects from ICU admission until ICU discharge
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start20 Jul 2020
- Primary completionJul 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 185 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mohd Shahnaz, MBBS, M Anes, University of Malaya
- Investigators
- MOHD SHAHNAZ HASAN, MBBS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533100
- Sponsor's protocol ID
- MREC ID NO: 2018222-6043
- Status last verified
- Sep 2020
- First submitted
- 27 Aug 2020
- Last updated
- 3 Sep 2020
- 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 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Protein-Energy Adequacy With Mortality in Critically Ill Patients With Acute Kidney Injury. A Prospective Observational Single- Centre Study.
- ClinicalTrials.gov ID
- NCT04533100
- Acronym / sponsor ID
- MREC ID NO: 2018222-6043
- Conditions
- Critical Illness, Acute Kidney Injury
- Keywords
- Protein, Energy, Adequacy, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 31 Aug 2020 (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.
This is a prospective observational single-center study in which the association of Protein-Energy Adequacy and 28-Days of Mortality among critically ill patients with Acute Kidney Injury, AKI will be investigated. The association of Protein-Energy adequacy with a length of ICU and hospital stay, total ventilator, and inotropic drug days among critically ill patients with AKI also will be investigated.
Detailed description
Patients with Acute Kidney Injury, AKI are probably more exposed to the risk of malnutrition especially if they undergo Renal Replacement Therapy, RRT. Optimization of nutrients especially energy and protein can ensure a better health outcome for critically ill patients with AKI. Moreover, there is no research on the association of Protein- Energy adequacy with mortality among critically ill patients with AKI in Malaysia. So, the main purpose of this study is to investigate the relationship of Protein-Energy adequacy with mortality among critically ill patients with AKI
Subjects will be recruited upon admission in ICU after fulfilling the inclusion and exclusion criteria. They will be follow up from day 1 until day 14 or until ICU Discharge. Data including Demographic, Clinical, Laboratory, and Nutritional Status will be recorded. On Day 28, the outcome data including Mortality, length of ICU Stay, and Length of Ventilator day will be recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 28 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be conducted in adult Intensive Care Unit, University Malaya Medical Centre (UMMC), Malaysia.
Key inclusion criteria (3 listed)
- Patients who are 18 years old and older
- Patients who are admitted to the participating ICU.
- Patients who are mechanically ventilated.
Key exclusion criteria (8 listed)
- Patients who are less than 18 years old
- End-stage renal disease patients
- Patients undergo kidney transplantation within 3 months before ICU admission
- Pregnant patients
- The patient is moribund with expected death within 24 hour or whom survival to 28 days is unlikely due to uncontrollable comorbidity (cardiac, pulmonary or hepatic end-stage disease; hepatorenal syndrome; poorly controlled cancer; severe post-anoxic encephalopathy and others)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-Days Mortality
Time frame: 1 day
Mortality status of subjects on day 28 from recruitment.
2 secondary outcomes
Length of ICU Stay
Time frame: 1 day
Length of Ventilator Day
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- ESPEN Guideline on Clinical Nutrition in the Intensive Care Unit. Clinical NutritionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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.
MOHD SHAHNAZ HASAN, MBBS principal investigator
University of Malaya
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 Critical Illness and Acute Kidney Injury, run by University of Malaya at 1 site in Malaysia.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Sep 2020. 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 Malaysia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MOHD SHAHNAZ HASAN, MBBS (0379493869 ext. 3869, shahnaz@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-Days Mortality (time frame: 1 day). 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 3 Sep 2020.