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Status unknownNCT03106831Updated Oct 11, 2017

Small Doses of Pituitrin Versus Norepinephrine for the Management of Vasoplegic Syndrome in Patients After Cardiac Surgery

An interventional study of Pituitrin infusion and Norepinephrine infusion in Postoperative Vasoplegic Syndrome, sponsored by Beijing Anzhen Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-11.

Sponsored by Beijing Anzhen Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Vasoplegic syndrome is a common complication after cardiac surgery. Low dose vasopressin can up-regulate blood pressure and improve clinical outcomes compared with norepinephrine (mainly acute kidney injury Anesthesiology 2017; 126:85-93). Pituitrin is used as a substitute for vasopressin in our center, which contains both vasopressin and oxytocin. Oxytocin may alleviate inflammatory process-associated kidney injury (Peptides 2006;27:2249-57). Therefore, the investigators hypothesize Pituitrin may be preferable to norepinephrine in the renal protection of patients with vasoplegic syndrome after cardiac surgery. Moreover, the serum levels of vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone will be measured.

02

Conditions studied

  • Postoperative Vasoplegic Syndrome
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients diagnosed as vasoplegic syndrome(defined as mean arterial pressure less than 65 mmHg resistant to fluid challenge and cardiac index greater than 2.2 L/min · m2) within 24 hours after cardiac surgery.

Exclusion criteria

Exclusion Criteria:

  1. Age \< 18 and > 75 years.
  2. Received renal replacement therapy before cardiac surgery.
  3. Diagnosed as endocrine disease before cardiac surgery.
  4. Diagnosed as sever peripheral vascular disease before cardiac surgery.
  5. Extracorporeal membrane oxygenation support before admission.
  6. To receive heart transplantation.
  7. Infection on admission.
  8. Pregnant or maternal patients.
  9. Refusal of consent
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Pituitrin arm

    To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

    Drug: Pituitrin infusion

  • Experimental
    Norepinephrine arm

    To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

    Drug: Norepinephrine infusion

Interventions

  • DrugPituitrin infusion

    To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

  • DrugNorepinephrine infusion

    To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.

05

What researchers measure

Primary outcomes

  1. Rate of in-hospital acute renal injury

    Acute renal injury (AKI) is defined as any of the following: (1) increase in serum creatinine (SCr) by ≥ 26.5lmol/l in 48 hours; (2) increase in SCr to ≥ 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or (3) urine output \< 0.5 ml/kg/h for 6 hours (urine output is only assessed when the CRRT machine is absent or with a fluid removal rate of 0 ml/h).

    Time frame: 30 days

Secondary outcomes

  1. In-hospital mortality

    All-cause mortality

    Time frame: 30 days

  2. Rate of new arrhythmias

    Rate of new arrhythmias after cardiac surgery

    Time frame: 30 days

  3. Hormone levels

    Serum hormone levels after cardiac surgery, including vasopressin, catecholamine, corticosteroid and corticotropin-releasing hormone

    Time frame: 30 days

  4. Rate of ECMO or LVAD support

    Receiving extracorporeal membrane oxygenation (ECMO) or left ventricle assist device (LVAD) support

    Time frame: 30 days

  5. Duration on ventilator support

    Duration on ventilator support after cardiac surgery

    Time frame: 30 days

  6. ICU length of stay

    ICU length of stay

    Time frame: 30 days

  7. Hospital length of stay after cardiac surgery

    Hospital length of stay after cardiac surgery

    Time frame: 30 days

06

Study locations

1 of 1 sites recruiting
  • Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
    Beijing, Beijing 100029, China
    • Hong Wang, PhD., MD. · Contact · 914286855@qq.com · 86 15010516438
    • Hong Wang, PhD., MD. · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03106831
Lead sponsor
Beijing Anzhen Hospital
Responsible party
Xiaotong Hou (Director of Center for Cardiac Intensive Care, Beijing Anzhen Hospital) — Principal investigator
First posted
Apr 10, 2017
Start date
Oct 10, 2017
Primary completion
Dec 31, 2018 (estimated)
Completion
Apr 30, 2019 (estimated)
Last update
Oct 11, 2017

Study contacts

Hong Wang, PhD., MD.
Contact
914286855@qq.com
86 15010516438

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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