Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity

Spine Deformity Clinical Trial

Official title:

A Prospective Study of Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04968483
• Other study ID #: LM2020093
• Status: Not yet recruiting
• Start date: September 1, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: July 2021
• Source: Peking University Third Hospital
• Contact: Ruifeng Xu
• Phone: +86 15011968861
• Email: xuruifeng0502[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the nutritional status, nutritional support and postoperative complications of patients undergoing spinal orthopedic surgery during the perioperative period.

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

1. general data: The information of gender, age, ethnicity, height, weight, course of disease, family history, combined diseases, medication etc.

2. 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.

3. 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.

4. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Emergency surgery;

• Hospital stay less than 24 hours;

• Surgery was not performed during the hospital stay;

• Nutritional metabolic diseases.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spine Deformity

Intervention

Other:
• Data collection
The general data, data of postoperative complications, data of nutritional assessment and nutritional support will be collected.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data of nutritional assessment and support	NRS2002 nutritional assessment results	Through the hospitalization, an average of 10 days.
Primary	Blood parameters about nutritional assessment and support	Hemoglobin values	Baseline
Primary	Blood parameters about nutritional assessment and support	blood hemoglobin values	Through the hospitalization after surgery, an average of 10 days.
Primary	Blood parameters about nutritional assessment and support	blood prealbumin values	Baseline
Primary	Blood parameters about nutritional assessment and support	Prealbumin values	Through the hospitalization after surgery, an average of 10 days.
Secondary	Complication rate	Postoperative complication rate during hospitalization and within 3 months after discharge.	After surgery to 3-month follow-up