NCT04182217

Descriptive and Correlational Study of Peritonitis in Haiti.

Completed Results posted Last updated 12 February 2020

What this trial tests

trial testing Epidemiological description in Peritonitis in 91 participants. Completed in 1 October 2019.

Timeline

10 September 2018

Primary endpoint
20 March 2019

1 October 2019

Quick facts

Lead sponsor	Universite d'Etat d'Haiti
Status	Completed
Study type	OBSERVATIONAL
Enrollment	91
Start date	10 September 2018
Primary completion	20 March 2019
Estimated completion	1 October 2019
Sites	1 location across Haiti

Drugs / interventions tested

• Epidemiological description

Conditions studied

• Peritonitis — all drugs for Peritonitis →

Sponsor

Universite d'Etat d'Haiti

Who can join

Adults 11 to 82, any sex, with Peritonitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Heart Rate Primary · immediately after admission, up to 30 minutes

Heart rate number of beats/min reported in the file entry for each patients

Group	Value	95% CI
Population	108.18	± 19.66

Respiratory Rate Primary · immediately after admission, up to 30 minutes

Respiratory rate number of cycle/min reported in the file of entry

Group	Value	95% CI
Population	28.58	± 8.51

Temperature Primary · immediately after admission, up to 30 minutes

Temperature in celsius reported in the file of entry

Group	Value	95% CI
Population	37.52	± 1.1

Blood Pressure Primary · immediately after admission, up to 30 minutes

Systolic Blood pressure in mmHg reported in the file of entry

Group	Value	95% CI
Population	110.93	± 14.86

Onset of Symptoms Secondary · immediately after admission

Days before coming at the hospital

Group	Value	95% CI
Population	6.9	± 8.1

Delay in Pre-op Secondary · immediately post-surgery

the pre-operative time in days which describes the time between the date of the intervention and the date of admission

Group	Value	95% CI
Population	3.73	± 3.61

Delay in Post-op Secondary · immediately after hospitalization

the time in days between the date of the intervention and the leaving of the patient at the hospital

Group	Value	95% CI
Population	9.19	± 10.93

Delay in Hospital Secondary · immediately after hospitalization

the time in days between the date of admission and the date of leaving the hospital

Group	Value	95% CI
Population	12.82	± 11.66

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 hours in post-operation rooms. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Population

Serious: 21/91 (23%)

Deaths: 3/91

Serious adverse events (1 terms)

Reaction	System	Population
Post-operative complications	Surgical and medical procedures	—

Most-reported serious reactions: Post-operative complications.

Data from ClinicalTrials.gov NCT04182217 adverse events section.

Sponsor's own description

The primary objective:

To study the prevalence, etiology, and factors associated with the severity of peritonitis and its complications in the surgery department of the State University Hospital of Haiti.

Secondary objectives:

* Identify epidemiological characteristics.
* Describe the main etiologies encountered in the service
* Measure the time required for treatment and its consequences on the evolution of peritonitis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.