NCT05603364

Brief Summary

To evaluate the effects of early oral carbohydrates after TKA on nutritional status, comfort and safety in elderly patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Nov 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

November 22, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 1, 2023

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 16, 2022

Last Update Submit

April 27, 2023

Conditions

Total Knee ArthroplastyPostoperative Oral CarbohydratesPostoperative RecoveryElderly Patients

Outcome Measures

Primary Outcomes (1)

  • Pre-albumin levels at fasting

    The change in prealbumin levels in venous blood in a fasting state in the early morning can reflect whether carbohydrate administration is favorable in the early postoperative period

    1 day after surgery

Secondary Outcomes (16)

  • Pre-albumin levels at fasting

    On the day of the surgery

  • Pre-albumin levels at fasting

    3 days after surgery

  • Retinol-binding protein levels at fasting levels

    Analyzed in early morning fasting venous blood samples at 3 time points： Operatively （day 0）， postoperatively（day1）， postoperatively（day3）

  • Insulin resistance index at fasting

    Analyzed in early morning fasting venous blood samples at 3 time points： Operatively （day 0）， postoperatively（day1）， postoperatively（day3）

  • The NRS score for the thirst condition

    2 hours, 6 hours and 8 hours after surgery

  • +11 more secondary outcomes

Study Arms (2)

EOF group：early carbohydrate feeding

EXPERIMENTAL

The EOF group drank 10.5% of 5 ml/kg body weight (100ml containing 12.5g maltodextrin, fructose and glucose) after extubation in the resuscitation room.

Combination Product: 100ml carbohydrate containing 12.5g maltodextrin, fructose and glucose

Control group：conventional feeding

EXPERIMENTAL

Patients in group C were observed with 60minutes of abnormal vital signs after extubation, and returned to the ward for fasting and fasting for at least 6 hours, and began to eat gradually through the mouth after anal exhaust.

Other: Routine feeding

Interventions

100ml carbohydrate containing 12.5g maltodextrin, fructose and glucoseCOMBINATION_PRODUCT

Drank 10.5% of 5 ml/kg body weight (100ml containing 12.5g maltodextrin, fructose and glucose) after extubation in the resuscitation room.

EOF group：early carbohydrate feeding
Routine feedingOTHER

Patients in group C were observed with 60min of abnormal vital signs after extubation, and returned to the ward for fasting and fasting for at least 6 h, and began to eat gradually through the mouth after anal exhaust

Control group：conventional feeding

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients undergoing elective knee replacement surgery.
  • The patient gave informed consent.
  • Age ≥65 years, Sex is not limited
  • American Society of Anesthesiologists (ASA)Ⅰ\~Ⅲ level
  • Body Mass Index (BMI)18\~28kg/m2

You may not qualify if:

  • Preoperative gastric emptying disorders, such as gastroesophageal reflux or previous surgery.
  • Diabetes mellitus, severe renal insufficiency, or other severe metabolic diseases.
  • History of motion sickness.
  • Mental disorders, alcoholism, or a history of substance abuse.
  • Patients with abnormal swallowing function.
  • Maltodextrin, fructose allergy or intolerance.
  • Surgery time was greater than 3 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (9)

  • Miller TE, Roche AM, Mythen M. Fluid management and goal-directed therapy as an adjunct to Enhanced Recovery After Surgery (ERAS). Can J Anaesth. 2015 Feb;62(2):158-68. doi: 10.1007/s12630-014-0266-y. Epub 2014 Nov 13.

    PMID: 25391735BACKGROUND

  • Rizvanovic N, Nesek Adam V, Causevic S, Dervisevic S, Delibegovic S. A randomised controlled study of preoperative oral carbohydrate loading versus fasting in patients undergoing colorectal surgery. Int J Colorectal Dis. 2019 Sep;34(9):1551-1561. doi: 10.1007/s00384-019-03349-4. Epub 2019 Jul 15.

    PMID: 31309323BACKGROUND

  • Nygren J, Thorell A, Ljungqvist O. Preoperative oral carbohydrate therapy. Curr Opin Anaesthesiol. 2015 Jun;28(3):364-9. doi: 10.1097/ACO.0000000000000192.

    PMID: 25827282BACKGROUND

  • [4] Surgery Branch of Chinese Medical Association, Anesthesiology Branch of Chinese Medical Society. Chinese Expert Consensus and Path Management Guidelines for Accelerating Rehabilitation Surgery (2018) [J]. Chinese Journal of Anesthesiology, 2018,38 (001): 8-13.

    BACKGROUND

  • Yang R, Tao W, Chen YY, Zhang BH, Tang JM, Zhong S, Chen XX. Enhanced recovery after surgery programs versus traditional perioperative care in laparoscopic hepatectomy: A meta-analysis. Int J Surg. 2016 Dec;36(Pt A):274-282. doi: 10.1016/j.ijsu.2016.11.017. Epub 2016 Nov 10.

    PMID: 27840308BACKGROUND

  • [6] Bethune Orthopaedic Accelerated Rehabilitation Alliance, Bethune Charity Foundation Orthopaedic Professional Committee of trauma, Joint Surgery Professional Committee of Bethune Charity Foundation, etc. Guidelines for the management of perioperative fasting fasting in orthopaedic surgery [J]. Chinese Journal of Trauma and Orthopedics, 2019,21 (10): 829-834.

    BACKGROUND

  • Smith MD, McCall J, Plank L, Herbison GP, Soop M, Nygren J. Preoperative carbohydrate treatment for enhancing recovery after elective surgery. Cochrane Database Syst Rev. 2014 Aug 14;2014(8):CD009161. doi: 10.1002/14651858.CD009161.pub2.

    PMID: 25121931BACKGROUND

  • Noba L, Wakefield A. Are carbohydrate drinks more effective than preoperative fasting: A systematic review of randomised controlled trials. J Clin Nurs. 2019 Sep;28(17-18):3096-3116. doi: 10.1111/jocn.14919. Epub 2019 Jun 10.

    PMID: 31112338BACKGROUND

  • [9] Wang Cuilan, Huang Yuting, Zeng Qing, et al. Study on postoperative fasting water prohibition time under ERAS concept [J]. Clinical Medical Engineering, 2022,29 (4): 2.

    BACKGROUND

MeSH Terms

Interventions

maltodextrinFructoseGlucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2022

First Posted

November 2, 2022

Study Start

November 22, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

May 1, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)