Effect of Mechanical Ventilation on Plasma Concentration Level of R-spondin Proteins

NCT03315702 | Completed Results

• 1 other identifier: XH-17-015
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

As novel agonists of Wnt/β-catenin signaling pathway, R-spondin proteins constitute a class of ligands, including R-spondin 1/2/3/4, functioning through their receptors leucine-rich repeat-containing G-protein coupled receptor (LGR)4/5/6 to enhance Wnt/β-catenin activity. Since Wnt signaling plays pivotal roles in the regulation of many life processes involved in embryogenesis and adulthood, R-spondin proteins also take part in cell proliferation, differentiation and morphogenesis.For example, in the formation of respiratory system，R-spondin 2 is required for normal laryngeal-tracheal and lung morphogenesis，and the lack of R-spondin 1 expression results in the absence of duct side-branching development and subsequent alveolar formation. In addition, R-spondins show protective effect in tissue injury and diseases. R-spondin 1 and R-spondin 3 have been reported to prevent chemotherapy- or radiotherapy-induced mucous membrane lesion. R-spondin 1 attenuates oral mucositis contributed by radiotherapy in mouse models and R-spondin 3 potentiates intestinal regeneration elicited via gastrointestinal toxic effect of chemoradiotherapy treatment. However, whether R-spondin proteins exert salient influence on acute lung injury especially induced by mechanical ventilation is deficient. Therefore, this study aims to ascertain the implication of R-spondin proteins in the pathology of mechanical ventilation induced lung injury through detecting human plasma concentration change of R-spondin 1/2/3/4 after mechanical ventilation and interference effects in mouse model, which is helpful for prevention and treatment of ventilation induced lung injury.

Conditions

Acute Lung Injury

Keywords

R-spondin proteins, mechanical ventilation, lung injury

Outcome Measures

Primary Outcomes (4)

• Change in Plasma Concentration of R-spondin 1

  The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin1 concentration. And the outcome was calculated by subtracting the R-spondin1 plasmid concentration of sample A from the R-spondin1 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin1.

  3 hours

• Change in Plasma Concentration of R-spondin 2

  The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin2 concentration. And the outcome was calculated by subtracting the R-spondin2 plasmid concentration of sample A from the R-spondin2 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin2.

  3 hours

• Change in Plasma Concentration of R-spondin3

  The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin3 concentration. And the outcome was calculated by subtracting the R-spondin3 plasmid concentration of sample A from the R-spondin3 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin3.

  3 hours

• Change in Plasma Concentration of R-spondin4

  The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation, which were named as sample A and sample B relatively. Then, plasmids were separated by centrifugation and detected for R-spondin4 concentration. And the outcome was calculated by subtracting the R-spondin4 plasmid concentration of sample A from the R-spondin4 plasmid concentration of sample B, which was the change in plasma concentration of R-spondin4.

  3 hours

Study Arms (1)

control／mechanical ventilation

venous blood samples collected from patients twice，relatively before mechanical ventilation and 3rd hour after mechanical ventilation

Other: mechanical ventilation

Interventions

mechanical ventilation OTHER

mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cm H2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5.

control／mechanical ventilation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

patients undergo elective surgery

You may qualify if:

• undergo elective surgery with mechanical ventilation lasting for \> 3 hours; classified as physical status I to III according to the American Society of Anesthesiologists Physical Status Classification System; Written informed consent is approved.

You may not qualify if:

• chronic lung disease; recent lung infection; recent anaesthetics or mechanical ventilation treatment; hemodilution with massive fluid supply during surgery; children；women during pregnancy or lactation; being involved in other clinical subjects

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Department of Anesthesia, Shanghai Xinhua hospital

Shanghai, Shanghai Municipality, 200082, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood samples from patients undergo elective surgery with general anesthesia and mechanical ventilation

MeSH Terms

Conditions

Acute Lung Injury; Lung Injury

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Results Point of Contact

• Title: Dr. Lai Jiang
• Organization: Department of Anesthesia, Xinhua hospital affiliated to Shanghai Jiaotong University School of medicine

jianglaimz@sina.com

021-25078999

Study Officials

• Lai Jiang, chief doctor

  Xinhua Hospital affiliated to Medicine school,Shanghai Jiaotong University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 20, 2017
• Study Start: September 22, 2017
• Primary Completion: October 15, 2017
• Study Completion: October 31, 2017
• Last Updated: July 25, 2019
• Results First Posted: July 25, 2019

Record last verified: 2017-10

Locations

CN (1)