Study on the effect of GDFT combined with low-dose meta-hydroxylamine on postoperative acute kidney injury in elderly patients: a randomized controlled trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100051089

Enrollment

Unknown

Registered

2021-09-12

Start date

2021-12-01

Completion date

Unknown

Last updated

2022-05-16

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

Conditions

Acute kidney injury

Interventions

test group:Target-oriented fluid therapy + continuous intravenous pump injection of low-dose meta-hydroxylamine (0.3µg/(kg·min)) 2 minutes before induction.

Control group:Goal-oriented fluid therapy + continuous intravenous pumping of normal saline at 2 minutes before induction

Eligibility

Sex/Gender

All

Age

65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 65 ~ 85 years; 2. Plan for elective laparoscopic surgery, general anesthesia is required; 3. Peripheral artery puncture and catheterization are required and the expected length of operation is >= 2 hours; 4. American Society of Anesthesiologist (ASA) classification I-III.

Exclusion criteria

Exclusion criteria: 1. Use of non-steroidal anti-inflammatory drugs in the past month; 2. Preoperative complicated with severe and difficult to control hypertension (SBP>=180mmhg or DBP>=110mmhg), hypertensive emergency, severe arrhythmia, valve stenosis, severe intracardiac shunt; 3. Acute cardiovascular events, including acute or decompensated heart failure and acute coronary syndrome; 4. Severe liver and kidney function and pulmonary insufficiency, chronic kidney disease CKD >= stage 4 (glomerular filtration rate < 30ml/min/1.73m2 or need renal replacement therapy or end-stage renal disease); 5. Urological surgery, emergency surgery; 6. Preoperative complicated with sepsis or shock state; 7. Preoperative hypotension (MAP < 65mmHg) requires the use of vasoactive drugs to maintain blood pressure, or controlled blood pressure during surgery or maintain blood pressure at a higher level; 8. The participant is participating in another clinical study or refuses to participate in this clinical study; 9. Peripheral vascular disease and contraindications for arterial catheterization; 10. Those who are deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

Measure	Time frame
Incidence of acute kidney injury;	—

Secondary

Measure	Time frame
Intraoperative hemodynamics;Incidence of intraoperative hypotension;Postoperative complications;	—

Countries

China

Contacts

Public ContactZou Wangyuan

Xiangya Hospital, Central South University

wangyuanzou@csu.edu.cn+86 13875814731

Outcome results

None listed

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