An observational study to compare the renal resistive index in postoperative shock versus non-shock patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean difference of RRI between shock & non-shock patients
研究概览
简要总结
Study will be conducted after the approval from the institutional ethical committee and
registration with Clinical Trials Registry of India (CTRI). Patients fulfilling the inclusion
criteria will be recruited for the study. A written and informed voluntary consent will be
obtained from the patient or next to kin, after carefully explaining the procedure, its benefits
and risks in his/her vernacular. Any postoperative patient who will develop hypotension in ICU
will be treated as per standard protocol and if hypotension will not be corrected within first
three hour of resuscitation, then the first value of renal resistive index will be measured between
first 3 to 6 hours of development of shock. Renal resistive index of the patients will be measured
with SonositeTM Edge II Total portable ultrasound machine and P19 phased curvilinear array
probe (2-5MHz) in supine position. The probe will be placed in posterior axillary line to get an
image of kidney. RRI will be measured from interlobar or arcuate arteries adjacent to medullary
pyramids. Three sequential reading from upper, median, lower lobe will be taken and its
average will give the final RRI. RRI is calculated by the formula:
RRI= (peak systolic velocity-end diastolic velocity)/peak systolic velocity
IVC measurement will be done in short axis view with phased array probe(1-5MHz) in supine
position in short axis view. The difference between IVC measurement during expiration (IVCE)
and IVC measurement during inspiration (IVCI) and IVC collapsibility index will be calculated
as IVCE-IVCI/IVCE to assess intravascular volume in relation to the central venous pressure.
Cardiac Index (CI), Pulse Pressure Index (PPI) will be seen from Edward VIGILEO monitor
and transducer, connected to FLOTRAC sensor. FLOTRAC sensor will be connected to the
radial artery catheter of the patients The sensor will be placed at the level of right atrium before
pressure equilibration(zeroing).
Following details will be noted from patients:
-
Age
-
Gender
-
APACHE II score
-
SOFA score
-
Inferior vena cava diameter and collapsibility with respiration.
-
Risk factors for AKI like sepsis, hypotension & diabetes.
-
Renal function assessed with pre admission creatinine, eGFR
-
Urinary indices like FENa, FEurea, albumin/creatinine ratio
-
Daily measurement of change in hemodynamic parameters like HR, MAP, PPI, CVP, CI,
vasopressors dose, serum lactate, serum urea, serum creatinine, urine output and RRI up to 3
days
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •In shock group:
- •More than 18year old
- •Either sex
- •Requiring Intensive care admission and diagnosed with shock.
- •In Non-shock group:
- •Requiring Intensive care admission due to any reason other than shock postoperatively.
排除标准
- •1.Patients with renal insufficiency (eGFR <90ml/min) by Modification of Diet in Renal Disease criteria.16 2.Patients with dialysis dependency
- •Patients with monokidney
- •Patients after renal transplant.
结局指标
主要结局
Mean difference of RRI between shock & non-shock patients
时间窗: 72 hours
次要结局
- Sensitivity & specificity, Positive Predictive Value, Negative Predictive Value of RRI to(predict AKI in both the groups.)
