Clinical trial NCT04968483: Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity
Official title: A Prospective Study of Perioperative Nutritional Status and Nutritional Support in Patients With Spinal Deformity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spine Deformity
Keywords: Spine deformity, Nutritional support, Postoperative complications
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopaedic patients with spine deformity

Brief summary: 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Data of nutritional assessment and support
timeFrame: Through the hospitalization, an average of 10 days.
measure: Blood parameters about nutritional assessment and support
timeFrame: Baseline
measure: Blood parameters about nutritional assessment and support
timeFrame: Through the hospitalization after surgery, an average of 10 days.
measure: Blood parameters about nutritional assessment and support
timeFrame: Baseline
measure: Blood parameters about nutritional assessment and support
timeFrame: Through the hospitalization after surgery, an average of 10 days.
Secondary outcomes:
measure: Complication rate
timeFrame: After surgery to 3-month follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Ruifeng Xu
role: PRINCIPAL_INVESTIGATOR
References: