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Effect of Vasopressin on Kidney and Cardiac Function in Septic Shock

NCT06125184 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-11-09

No results posted yet for this study

Summary

Septic shock is a syndrome characterized by tissue hypoperfusion and hypotension secondary to an uncontrolled infection. It is a frequent cause of admission to the intensive care unit (ICU) and has an associated mortality around 40%. Around 50 % of septic shock patients exhibit early acute kidney injury and 30 to 40% will require renal replacement therapy.

After initial fluid resuscitation most of the patients with septic shock become hyperdynamic but still require norepinephrine (NE) to maintain a mean arterial pressure (MAP) above 65 mmHg. The optimal perfusion pressure may vary, specially in previously hypertensive patients as they may have a shift to the right in their kidney auto-regulatory curve. In a previous study in patients with chronic hypertension and septic shock, increasing MAP from 65 mmHg to 85 mmHg with NE was associated with improved renal function. However, the incidence of tachyarrhythmias increased, associated to the higher NE doses required, which has raised some concerns about the safety of this strategy. In this setting, the addition of vasopressin (AVP), a drug used as a vasopressor but with cathecholamine independent mechanisms, may allow to prevent this side effect by decreasing NE dose requirements. Low doses of AVP appear to be safe and when combined with NE in septic shock patients, it resulted in increased creatinine clearance and decreased use of renal replacement therapy, compared to NE alone. Theoretically, AVP can improve glomerular filtration rate. Therefore, the addition of AVP to NE in previously hypertensive septic shock patients should be a reasonable strategy to improve organ perfusion.

Furthermore, AVP could be an important step towards decatecholaminization in the management of septic shock patients. However, its effect on cardiac performance and stroke volume when targeting high MAP is unclear.

Conditions

  • Kidney Injury, Acute
  • Cardiac Function Failed

Interventions

DRUG

Vasopressor test

Mean arterial pressure will be increased from 65 mmHg to 85 mmHg to improve organ perfusion pressure.

Sponsors & Collaborators

  • FONDECYT de iniciación 11201220

    collaborator UNKNOWN

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Emilio Daniel Valenzuela Espinoza, MD · Pontificia Universidad Catolica de Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2024-10-01
Completion
2025-01-01

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06125184 on ClinicalTrials.gov