Nutrition Therapy for Critical IllnessNCT02831725
An Observational Cohort Study to Establish Accurate Nutrition Therapy for Critically Ill Patients
An observational study of Nutrition Therapy for Critical Illness, run by Peking Union Medical College Hospital.
Trial summary
1. Demographics data; 2. Nutritional evaluation data; 3. All biochemical monitoring data during the study period; 4. All nutritional treatment data will be recorded daily during the study period, including actual calorie intake, protein intake, and the proportion of calorie/protein administered by EN and/or PN route. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nutrition Therapy for Critical Illness
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jul 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospitalized adult patients
Who may be able to join
- age: 18-70
- patients are underwent Whipple operation or subtotal gastrectomy and ever admitted to intensive care unit (ICU) after the operation
- receive parenteral or enteral nutrition > 3 days
Who cannot join
- has metabolic disorders: diabetes, thyroid disease
- Pregnant or breastfeeding
- The presence of drug or alcohol dependence
- The presence of tuberculosis, HIV infection and other acute infectious disease
- Serious liver, kidney, heart and other vital organ failure
Trial locations and contacts
No sites are listed yet.
About this study
- Demographics data;
- Nutritional evaluation data;
- All biochemical monitoring data during the study period;
- All nutritional treatment data will be recorded daily during the study period, including actual calorie intake, protein intake, and the proportion of calorie/protein administered by EN and/or PN route. The nutritional treatment protocol will be decided by the attending physician, the investigator will not intervene.
- A blood sample (5 ml) will be drawn from every patient immediately after they enroll into the study, and the metabolomics of the samples will be analyzed analysis using a combined 800 MHz 1H-NMR-UPLC-MS system. The data will then be used to establish metabolic profile baseline.
- We will establish a sub-group that contains 20 patients (chosen from enrolled patients according to APACHE II scores: 10 patients are APACHE II scores in 21-30). We will take one blood sample daily during the whole study period. The plasma sample will be used for metabolomics analysis using an 800 MHz 1H-NMR-UPLC-MS system. And the data will be used for metabolic dynamic modeling.
- Clinical outcomes data, which include: 1) Complications after the operation (intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection); 2) death event; 3) ICU-stay; 4) Length of hospitalization
- Conditions
- Nutrition Therapy for Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
complications after the operation
intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition Therapy for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831725
- Sponsor's protocol ID
- HS-991
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cohort Study to Establish Accurate Nutrition Therapy for Critically Ill Patients
- ClinicalTrials.gov ID
- NCT02831725
- Acronym / sponsor ID
- HS-991
- Conditions
- Nutrition Therapy for Critical Illness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jul 2016
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 13 Jul 2016 (estimated)
- 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.
- Demographics data;
- Nutritional evaluation data;
- All biochemical monitoring data during the study period;
- All nutritional treatment data will be recorded daily during the study period, including actual calorie intake, protein intake, and the proportion of calorie/protein administered by EN and/or PN route. The nutritional treatment protocol will be decided by the attending physician, the investigator will not intervene.
- A blood sample (5 ml) will be drawn from every patient immediately after they enroll into the study, and the metabolomics of the samples will be analyzed analysis using a combined 800 MHz 1H-NMR-UPLC-MS system. The data will then be used to establish metabolic profile baseline.
- We will establish a sub-group that contains 20 patients (chosen from enrolled patients according to APACHE II scores: 10 patients are APACHE II scores in 21-30). We will take one blood sample daily during the whole study period. The plasma sample will be used for metabolomics analysis using an 800 MHz 1H-NMR-UPLC-MS system. And the data will be used for metabolic dynamic modeling.
- Clinical outcomes data, which include: 1) Complications after the operation (intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection); 2) death event; 3) ICU-stay; 4) Length of hospitalization
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospitalized adult patients
Key inclusion criteria (3 listed)
- age: 18-70
- patients are underwent Whipple operation or subtotal gastrectomy and ever admitted to intensive care unit (ICU) after the operation
- receive parenteral or enteral nutrition > 3 days
Key exclusion criteria (5 listed)
- has metabolic disorders: diabetes, thyroid disease
- Pregnant or breastfeeding
- The presence of drug or alcohol dependence
- The presence of tuberculosis, HIV infection and other acute infectious disease
- Serious liver, kidney, heart and other vital organ failure
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
complications after the operation
Time frame: three years
intestinal fistula, pancreatic fistula, biliary fistula and sepsis, bleeding, nosocomial infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
Related trials for Nutrition Therapy for Critical Illness
Recruiting
Will the Use of Respiratory Quotient ''RQ'' Improve Treatment Outcomes for Intensive Care Unit (ICU) Patients?
Nutritional Therapy in an ICU, Critically Ill Patients Requiring Mechanical Ventilation
Recruiting
mNEED: a Multicentre, Cluster-randomized, Controlled Trial
Feeding, ICU
Not yet recruiting
Optimizing Enteral Nutrition Regimen for Critically Ill Patients
Critical Illness, Enteral Nutrition
Recruiting
Comparing High-protein Vs. Standard Protein Nutritional Support in Critically Ill Patients At Risk for Refeeding Syndrome
Critical Illness, Malnutrition
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Therapy for Critical Illness, run by Peking Union Medical College Hospital.
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 5 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Wei Chen (8613911006820, txchenwei@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications after the operation (time frame: three years). 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 Jul 2016.