Spine DeformityNCT04968483
Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity
An observational study of Spine Deformity, run by Peking University Third Hospital at 1 site in China.
Trial summary
To investigate the nutritional status, nutritional support and postoperative complications of patients undergoing spinal orthopedic surgery during the perioperative period. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Spine Deformity
- What is being tested?
- Data collection
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Mar 2022
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Orthopaedic patients with spine deformity
Who may be able to join
- Diagnosis of spine deformity, complete the operation in one time；
- Age: More than 10 years old ；
- Patients and their family members agreed to participate in the study and signed the informed consent；
- Conscious, patient or family members can communicate verbally.
Who cannot join
- Emergency surgery；
- Hospital stay less than 24 hours；
- Surgery was not performed during the hospital stay；
- Nutritional metabolic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Ruifeng Xu, +8615011968861
About this study
Official title: A Prospective Study of Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity
To investigate the nutritional status, nutritional support and postoperative complications of patients undergoing spinal orthopedic surgery during the perioperative period.
Read the detailed description
Adopting the method of continuous fixed point sampling, the inpatients in the orthopedic ward of our hospital were selected as the objects of investigation.
(1) Data collection
- general data: The information of gender, age, ethnicity, height, weight, course of disease, family history, combined diseases, medication etc.
- Nutritional assessment：①Nutritional risk screening tool 2002(NRS 2002), an evidence-based nutritional risk screening tool developed by the European Society for Parenteral and Endoenteral Nutrition, was recommended by the Chinese Society for Parenteral and Endoenteral Nutrition as a nutritional risk screening tool for inpatients in China. The total NRS 2002 was divided into three scores, namely disease severity score, impaired nutritional status score and age score. NRS 2002 score ≥3 (accompanied by poor general conditions, such as weight loss, appetite, mental state, etc.) are at nutritional risk and require nutritional support; Those with a score less than 3 have no nutritional risk and do not need nutritional support. ②Other indicators include height, weight and body mass index, as well as biochemical indicators such as pre-albumin and hemoglobin. Nutritional assessment was performed within 24 hours of admission, on the 1d after surgery, on the 7d after surgery, every 7d after surgery, or upon discharge. NRS 2002 was repeated to assess patients' nutritional risk at the first review three months after discharge.
- Nutritional support: The nutritional support received during the hospital was recorded, including the form of nutritional support (enteral or parenteral nutrition), energy ratio, variety selection, duration of administration, etc. 1 g carbohydrate provided 16.74 kJ(4 kcal) calories, 1 g fat milk provided 38.93 kJ(9.3 kcal) calories and 1 g amino acid provided 16.74 kJ(4 kcal) calories to calculate the energy provided by the nutritional support program. The amount of nitrogen provided by the nutritional support program was calculated with about 1 g nitrogen provided by 6.25 g amino acids.
- Complications: Postoperative complications, such as sepsis, pneumonia, urinary tract infection, wound infection, and delayed wound healing, were recorded during hospitalization and within 3 months after discharge.
- Conditions
- Spine Deformity
- Being tested
- Data collection
- Keywords
- Spine deformity, Nutritional support, Postoperative complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
The general data, data of postoperative complications, data of nutritional assessment and nutritional support will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with spine deformity undergoing surgical treatment Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data of nutritional assessment and support
NRS2002 nutritional assessment results
Measured: Through the hospitalization, an average of 10 days.
Blood parameters about nutritional assessment and support
Hemoglobin values
Measured: Baseline
Blood parameters about nutritional assessment and support
blood hemoglobin values
Measured: Through the hospitalization after surgery, an average of 10 days.
Blood parameters about nutritional assessment and support
blood prealbumin values
Measured: Baseline
Blood parameters about nutritional assessment and support
Prealbumin values
Measured: Through the hospitalization after surgery, an average of 10 days.
Secondary outcomes (1)
Complication rate
Postoperative complication rate during hospitalization and within 3 months after discharge.
Measured: After surgery to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DeformityStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruifeng Xu, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968483
- Sponsor's protocol ID
- LM2020093
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity
- ClinicalTrials.gov ID
- NCT04968483
- Acronym / sponsor ID
- LM2020093
- Conditions
- Spine Deformity
- Keywords
- Spine deformity, Nutritional support, Postoperative complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 20 Jul 2021 (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.
To investigate the nutritional status, nutritional support and postoperative complications of patients undergoing spinal orthopedic surgery during the perioperative period.
Detailed description
Adopting the method of continuous fixed point sampling, the inpatients in the orthopedic ward of our hospital were selected as the objects of investigation.
(1) Data collection
- general data: The information of gender, age, ethnicity, height, weight, course of disease, family history, combined diseases, medication etc.
- Nutritional assessment：①Nutritional risk screening tool 2002(NRS 2002), an evidence-based nutritional risk screening tool developed by the European Society for Parenteral and Endoenteral Nutrition, was recommended by the Chinese Society for Parenteral and Endoenteral Nutrition as a nutritional risk screening tool for inpatients in China. The total NRS 2002 was divided into three scores, namely disease severity score, impaired nutritional status score and age score. NRS 2002 score ≥3 (accompanied by poor general conditions, such as weight loss, appetite, mental state, etc.) are at nutritional risk and require nutritional support; Those with a score less than 3 have no nutritional risk and do not need nutritional support. ②Other indicators include height, weight and body mass index, as well as biochemical indicators such as pre-albumin and hemoglobin. Nutritional assessment was performed within 24 hours of admission, on the 1d after surgery, on the 7d after surgery, every 7d after surgery, or upon discharge. NRS 2002 was repeated to assess patients' nutritional risk at the first review three months after discharge.
- Nutritional support: The nutritional support received during the hospital was recorded, including the form of nutritional support (enteral or parenteral nutrition), energy ratio, variety selection, duration of administration, etc. 1 g carbohydrate provided 16.74 kJ(4 kcal) calories, 1 g fat milk provided 38.93 kJ(9.3 kcal) calories and 1 g amino acid provided 16.74 kJ(4 kcal) calories to calculate the energy provided by the nutritional support program. The amount of nitrogen provided by the nutritional support program was calculated with about 1 g nitrogen provided by 6.25 g amino acids.
- Complications: Postoperative complications, such as sepsis, pneumonia, urinary tract infection, wound infection, and delayed wound healing, were recorded during hospitalization and within 3 months after discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Data collectionPatients with spine deformity undergoing surgical treatment |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Orthopaedic patients with spine deformity
Key inclusion criteria (4 listed)
- Diagnosis of spine deformity, complete the operation in one time；
- Age: More than 10 years old ；
- Patients and their family members agreed to participate in the study and signed the informed consent；
- Conscious, patient or family members can communicate verbally.
Key exclusion criteria (4 listed)
- Emergency surgery；
- Hospital stay less than 24 hours；
- Surgery was not performed during the hospital stay；
- Nutritional metabolic diseases.
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 |
|---|---|---|
| Data collectionThe general data, data of postoperative complications, data of nutritional assessment and nutritional support will be collected. | Other | Study group |
Primary outcome
Data of nutritional assessment and support
Time frame: Through the hospitalization, an average of 10 days.
NRS2002 nutritional assessment results
Blood parameters about nutritional assessment and support
Time frame: Baseline
Hemoglobin values
Blood parameters about nutritional assessment and support
Time frame: Through the hospitalization after surgery, an average of 10 days.
blood hemoglobin values
Blood parameters about nutritional assessment and support
Time frame: Baseline
blood prealbumin values
Blood parameters about nutritional assessment and support
Time frame: Through the hospitalization after surgery, an average of 10 days.
Prealbumin values
1 secondary outcome
Complication rate
Time frame: After surgery to 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Ruifeng Xu principal investigator
Peking University Third Hospital
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 Spine Deformity, run by Peking University Third Hospital 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 4 inclusion and 4 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 20 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruifeng Xu (+86 15011968861, xuruifeng0502@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data of nutritional assessment and support (time frame: Through the hospitalization, an average of 10 days.). The study lists 5 primary outcomes in all. 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 20 Jul 2021.