Therapeutic effects of intravenous lipid emulsion in tricyclic antidepressants toxicity

Comparison of therapeutic effects of bicarbonate and bicarbonate plus intravenous lipid emulsion in tricyclic antidepressants toxicity

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2012061610017N2

Enrollment

108

Registered

2012-07-24

Start date

2012-04-25

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Tricyclic antidepressants toxicity. Poisoning by psychotropic drugs, not elsewhere classified/Tricyclic and tetracyclic antidepressants

Interventions

Intervention 1: Control: standard treatment of TCA toxicity which contains GI decontamination, fluid resuscitation, and intravenous bicarbonate. Intervention 2: Intervention: standard treatment of TCA

Treatment - Drugs

Control: standard treatment of TCA toxicity which contains GI decontamination, fluid resuscitation, and intravenous bicarbonate.

Intervention: standard treatment of TCA toxicity which contains GI decontamination, fluid resuscitation, and intravenous bicarbonate plus 100 cc intravenous lipid emulsion 20% in 1 min and 400 cc in 2

Eligibility

Sex/Gender

All

Age

16 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: all patients with TCA toxicity according to patient history by himself or other sources of history, who are over 16 and have the indication for starting bicarbonate therapy. Exclusion criteria: patients with renal failure; pulmonary edema; brain edema; toxication with carbamazepine or phenothiazine in addition to TCA.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Normalization time for blood pressure. Timepoint: Minutes of 30, 60, 90, 240, 480 and 720. Method of measurement: Patients’ blood pressure would be detected by mercury barometer in mmHg and the time that blood pressure reach above 90 mmHg will be noted.;Normalization time for EKG. Timepoint: Minutes of 30, 60, 90, 240, 480 and 720. Method of measurement: Checklists to be filled by the patients physician.	—

Measure

Time frame

Normalization time for blood pressure. Timepoint: Minutes of 30, 60, 90, 240, 480 and 720. Method of measurement: Patients’ blood pressure would be detected by mercury barometer in mmHg and the time that blood pressure reach above 90 mmHg will be noted.;Normalization time for EKG. Timepoint: Minutes of 30, 60, 90, 240, 480 and 720. Method of measurement: Checklists to be filled by the patients physician.

—

Secondary

Measure	Time frame
Fnal mortality and morbidity. Timepoint: At the patient discharge time. Method of measurement: Observation.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Movahedi Behnam

School of medicine, Tehran University of Medical Sciences

behnam2980@gmail.com+98 21 6652 5327

Outcome results

None listed

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