跳至主要内容
临床试验/CTRI/2023/04/051342
CTRI/2023/04/051342尚未招募不适用

Renal recovery in hospital acquired AKI: A multicenter non intervention observational study

Indian Society of Critical Care Medicine6 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年1月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
试验地点
6
主要终点
Survival and renal recovery after developing HAAKI

研究概览

简要总结

Background: Development of acute kidney injury (AKI) in hospitalized patients is associated with increased length of intensive care unit (ICU) stay, prolonged hospital stay as well as higher mortality and morbidity. 1,2,3 The incidence of AKI with various degree of severity ranges from 1–25% of ICU admission.4 The incidence of the disease seems to be increasing possibly due to a parallel increase in the number of elderly, more severely and chronically ill patients.5

 Objective: To study the pattern of renal recovery in patient who developed AKI in hospital/ ICU.

Criteria for AKI: As per the KDIGO guidelines6

AKI is defined as any of the following:  Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or Urine volume < 0.5 ml/kg/h for 6 hours.

**Criteria for renal recovery6,**7,8

·        Complete: Renal function returned to base line with adequate urine output/ No intervention required

·        Partial with no RRT: Decline in severity stage,Declining trend of creatinine,Renal dysfunction still existing with urine output> 500 ml/dayand no need of Renal replacement therapy.

·        Partial with RRT requirement: Urine output less than 500 ml/day and requiring RRT infrequently.

·        Non recovery with RRT dependent: Urine output<300 ml/day and planned for RRT on regular basis.

**Method:**Prospective observational study for a period 3 month (1st Sep 2022- 30 Nov 2022) will be performed in various ICU’s across the India. The data will be collected for 30 days or till discharge (whichever is earlier) from the date of AKI diagnosis.

**Inclusion:**All patients who developed AKI after 48 hour of hospital admission.

Age 18 years & above

Exclusion: CKD patients or any patient who has developed AKI prior to admission or within 48 hours

(However patient transferred from other health care facility with available records showing development of AKI within 48 hour of admission in the transferring hospital may be included in the study)

Nephrotoxic drugs: If a patient had received a drug with known nephrotoxic potential for a minimum period of two days prior to the defined increase in serum creatinine concentration.

Sepsis:9Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.

Organ dysfunction can be identified as an acute change in total SOFA score ≥2 points consequent to the infection.

·        The baseline SOFA score can be assumed to be zero in patients not known to have pre-existing organ dysfunction.

·        A SOFA score ≥2 reflects an overall mortality risk of approximately 10% in a general hospital population with suspected infection. Even patients presenting with modest dysfunction can deteriorate further, emphasizing the seriousness of this condition and the need for prompt and appropriate intervention, if not already being instituted.

In lay terms, sepsis is a life-threatening condition that arises when the body’s response to an infection injures its own tissues and organs.

**Hypotension:**Systolic blood pressure BP <90 mm Hg, inspite of adequate fluid resuscitation

Hypovolemia: If there was obvious cause of volume depletion along with loss of skin turgor with decrease of more than 5% of body weight

Type of AKI

Possible Prerenal/ Renal/ Post Renal

On clinical judgement of intensivist/ nephrologist

Confirmed Prerenal/Renal/ Postrenal(as per the clinical need on treating physician decision)

Urine analysis (Blood/ Protein)

Urinary Na/ Urinary Creatinine

FENa

USG Abdomen

Primary outcome:

·        Survival and renal recovery after developing HAAKI

Secondary outcome

·        Pattern of HAAKI in various ICU (Staging, Risk factors, Aetiological factor)

·        Need of interventions besides correcting the underlying cause (Use of RRT/ Diuretic boluses or infusions)

Data collection:

·        Demographics

·        Date of Admission

·        Date of AKI diagnosis/ Grade or severity of AKI (note the worst)

·        Urine output: At admission/ at Diagnosis of AKI/ Worst value during the course/ at the time of study completion/discharge

·        Serum creatinine: At admission/ at Diagnosis of AKI/ Worst value during the course/ at the time of study completion/discharge

·        SOFA score

·        Type of patient/ ICU: Surgical/ Medical/ Others

·        Primary diagnosis

·        Comorbidities

o   Coronary artery disease

o   CHF

o   Chronic lung disease

o   Malignancy (Specify…)

o   Hypertension

o   DM

o   Metabolic syndrome

o   Chronic liver disease

·        Surgery/ intervention (if any)

·        Most probable cause of AKI (you may select more than one)

o   Nephrotoxic drugs

o   Haemodynamic instability

o   Volume loss

o   Low cardiac output

o   Post CPR survivor

o   Sepsis

·        Possible type of AKI

o   Pre renal

o   Renal

o   Post renal

o   Unknown

·        Other organ dysfunction during current admission

o   Hepatic

o   Cardiac

o   Neurological

o   Respiratory

·        Other organ support

o   Respiratory (O2/ HFNO/NIV/ Mechanical ventilation)

o   VIS (Vasoactive Inotropic Score)

o   Other Cardiac Support (IABP/ ECMO/ TPI etc)

·        Management of AKI

·        No intervention

·        Medical management (Diuretics type & method)

·        Renal replacement therapy (Type/ duration/ indication/ no of cycles)

·        Outcome

A.

·        Still hospitalized

·        Discharged

·        DAMA

·        Death

B.

o   Complete recovery

o   Partial with No RRT

o   Partial with RRT requirement

o   Non recovery with RRT dependent

Analysis: SPSS latest version with appropriate test will be used for analysis and P<0.5 will be considered significant.

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

  • The patients who developed AKI after 48 hours hospitalization.

排除标准

  • 未提供

结局指标

主要结局

Survival and renal recovery after developing HAAKI

时间窗: Discharge from hospital or 30 days from the day of HAAKI diagnosis, whichever is earlier

次要结局

  • •Pattern of HAAKI in various ICU (Staging, Risk factors, Etiological factor)(•Need of interventions besides correcting the underlying cause (Use of RRT/ Diuretic boluses or infusions))

研究者

申办方类型
Research institution

研究点 (6)

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