An interventional study of Terlipressin treatment and Usual care in Septic Shock, sponsored by Southeast University, China. Completed at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-07-01.
Sponsored by Southeast University, China · Not applicable, Interventional, and Treatment
This open-label, randomized controlled trial aimed to investigate the effect of a fixed dose of terlipressin added to usual care vs. usual care alone on renal perfusion in patients with septic shock.
Terlipressin is a synthetic vasopressin analog with great affinity to the V1 receptor (vasoconstrictive effect), and could selectively contract efferent arterioles, increase glomerular filtration pressure and renal perfusion. The investigators conducted this open-label, randomized controlled trial to observe the effects of a fixed dose of terlipressin added to usual care vs. usual care alone on renal perfusion in patients with septic shock. Renal perfusion was monitored by renal contrast-enhanced ultrasound. The primary outcome was peak intensity (renal perfusion parameter) at 24 hours after enrollment.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 22 is below the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Southeast University, China is the lead sponsor of 164 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the terlipressin group received a fixed dose of terlipressin added to usual care. Terlipressin was intravenously pumped at a fixed dose of 1.3μg/kg/hour for 24 hours.
Drug: Terlipressin treatment
Patients in the usual care group were treated with standard care.
Drug: Usual care
Patients in the terlipressin group received a fixed dose of terlipressin added to usual care. Terlipressin was intravenously pumped at a fixed dose of 1.3μg/kg/hour for 24 hours.
Patients in the usual care group were treated with standard care, according to the international guidelines for the management of sepsis and septic shock.
Peak intensity
Peak intensity is the peak concentration of contrast agent, a kind of renal perfusion parameter monitored by renal contrast-enhanced ultrasound.
Time frame: 24 hours after enrollment
urine output, mL
urine output with 24 hours
Time frame: 24 hours after enrollment
The incidence of acute kidney injury
Defined as serum creatinine increase≥50% within seven days or increase≥26.5 μmol/L within 48 hours
Time frame: Within 28 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Southeast University, China