Skip to content

Randomized controlled trial for efficacy and safety of perioperative stress ulcer prophylaxis in orthopedic patients

Randomized controlled trial for efficacy and safety of perioperative stress ulcer prophylaxis in orthopedic patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025417
Enrollment
Unknown
Registered
2019-08-26
Start date
2019-09-15
Completion date
Unknown
Last updated
2019-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

perioperative stress ulcer prophylaxis in orthopedic patients

Interventions

Hip and knee replacement treatment group:Application of antigastric acid drugs
Hip and knee replacement control group:Routine management
Elderly trauma PPI group:PPI
Elderly trauma H2 receptor antagonist group:H2 receptor receptor antagonist

Sponsors

Beijing Hospitals Authority
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) the age of patients with hip and knee replacement should over 18 years old; Aged patients should over 65 years old; (2) patients planning to undergo surgery; (3) estimated length of hospitalization should over 48 hours.

Exclusion criteria

Exclusion criteria: (1) gestation and lactation; (2) preoperative acid-inhibiting treatment or indications of acid-inhibiting treatment, such as peptic ulcer, reflux esophagitis, drobe syndrome, gastrointestinal bleeding, and receiving dual anti-platelet therapy (aspirin and clopidogrel); (3) patients with digestive system symptoms such as nausea, vomiting, abdominal pain, abdominal distension and acid reflux before surgery. (4) severe liver dysfunction (child-pugh score grade C); (5) severe renal insufficiency (creatinine clearance rate < 30mL/min); (6) solid organ transplantation (liver transplantation, kidney transplantation, etc.); (7) the clinical evaluation is not suitable for inclusion in the group (at least two project team members should agree, including at least one clinical expert, to record the reasons for the ineligibility).

Design outcomes

Primary

MeasureTime frame
Hemoglobin;

Secondary

MeasureTime frame
ALT;ALP;serum creatinine;

Countries

China

Contacts

Public ContactZhen jiancun

Beijing Jishuitan Hospital

zhenjiancun@163.com+86 13901180735

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026