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Medical management of compartment syndrome

Randomized double-blind placebo controlled clinical trial to determine the efficacy of mannitol in reducing intra-compartmental pressure - MRCS study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/11/003089
Enrollment
40
Registered
2012-11-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients with Isolated, Closed and Gustilo Anderson type I open proximal 2/3rd tibia fractures (Intracompartmental pressure in the leg are measured in these patients).

Interventions

Intervention1: Intracompartmental pressure measurement: Intracompartmental pressure is measured before giving and 1 and 3 hours after giving the agents by stryker hand held pressure monitor. Control I

Sponsors

Christian Medical College Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients presenting to emergency department with isolated acute, closed and Gustilo Anderson type I open, proximal 2/3rd tibia fracture.

Exclusion criteria

Exclusion criteria: Patients with contraindication to mannitol are excluded (heart failure, pulmonary congestion, hypotension, anuria, liver failure, intracranial bleed) .

Design outcomes

Primary

MeasureTime frame
1. The mean reduction in the compartment pressures in normal saline group and mannitol group. This will be measured 1 hr and 3 hours after giving the study and comparator drug. It will be measured by Dr. N. Jerry in all patients. 2. The number of patients in whom compartment syndrome develops. This is based on the clinical criteria.Timepoint: Pressures are measured before giving the agents and 1 and 3 hours after administration.

Secondary

MeasureTime frame
Side effect profile of mannitol drug.Timepoint: Number developing renal failure in mannitol group.

Countries

India

Contacts

Public ContactDr Thilak

Christian Medical College Hospital

thilakjepegnanam@yahoo.com9489592001

Outcome results

None listed

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